Mammography Facility Adverse Event and Action Report - April 23, 2015
Background As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide.
In order to provide this information in the timeliest manner, we now post the following information in “real time,” as actions taken against mammography facilities are concluded:
Mammography Facility and Adverse Action
The State of Pennsylvania
Facility Name and Address: Lancaster Breast Imaging 2170 Noll Dr., Ste. 200 Lancaster, PA 17603
Facility ID Number: 239076
Adverse Event: On January 30, 2015, the Lancaster Breast Imaging facility self-reported to the Pennsylvania Bureau of Radiation Protection (PA BRP) Regional Office that 47 patients did not receive their lay summary reports within 30 days. The facility discovered that patients imaged between December 24, 2014 and December 26, 2014 did not receive their lay summary letters within 30 days. All of the referring physicians received the mammography results within the 30 day period.
Action Taken: On March 12, 2015, the facility met with the PA BRP Regional office to discuss the violations and the parties agreed to a $6,950.00 fine. Both parties entered into a Consent Order and Agreement. The enforcement document details the FDA MQSA regulations, violations and corrective actions to be taken by the facility.
Corrective Action: The facility was instructed to revise its patient notification procedure, document that staff received communication concerning the changes, perform an annual audit of policy compliance and verbally inform patients that they will receive a letter and steps to follow if the letter is not received.
Status of the Facility: The facility is performing mammography.
SM Fish Corp. of FAR ROCKAWAY, NY is recalling 8 ounce containers of OSSIES HERRING IN SOURCREAM and OSSIES PICKLED LOX DAIRY because they contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reactions if they consume these products
SM Fish Corp. of FAR ROCKAWAY, NY is recalling 8 ounce containers of OSSIE’S PICKLED LOX & CREAM because it contains undeclared eggs. People who have an allergy to eggs run the risk of serious or life-threatening allergic reaction if they consume this product.
Including certain lots of Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe Congestion & Cough and Mucinex Fast-MAX Cold, Flu & Sore Throat
AUDIENCE: Consumer
ISSUE: RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe Congestion & Cough and Mucinex Fast-MAX Cold, Flu & Sore Throat because the over-the-counter medications, which correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the back. This mislabeling could cause the consumer to be unaware of side effects and/or risks associated with the ingestion of certain product ingredients which include acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine.
Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine. Consumers would not be adequately warned of side effects which could potentially lead to health complications requiring urgent medical intervention, particularly in the case of acetaminophen use in people with liver impairment.
BACKGROUND: RB is notifying its distributors and customers by direct correspondence. See the press release for a listing of affected product lot numbers.
RECOMMENDATION: RB is asking consumers to responsibly dispose of any unused product in accordance with the following recommended guidance for drug disposal in your household trash:
Mix liquid medicines with an unpalatable substance such as kitty litter or used coffee grounds;
Place the mixture in a container such as a sealed plastic bag; and
Throw the container in your household trash.
Consumers who have purchased this product can also contact the RB MUCINEX FAST-MAX recall toll free number at 1-888-943-4215 between the hours of 8:00 a.m.- 8:00 p.m eastern standard time with any questions or to speak with a representative, and should refer to www.mucinex.com/recall for the accurate related drug facts information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
This month is Sexual Assault Awareness Month—a time to help communities understand sexual violence and prevent it using best-available evidence.
What You Need To Know
Nearly 1 in 5 women (19%) and 1 in 59 men (nearly 2%) in the U.S. have been raped in their lives. 1 in 15 men have been made to penetrate someone in their lives.
Most first-time sexual assaults occur before age 18, making early intervention and prevention efforts critical—for women and men.
