KIT: CIRCUMCISION 20/CS

Additional Manufacturer Narrative

INCIDENT 4 OF 9. THE PRODUCT INVOLVED IN THE EVENT IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF THE CIRCUMCISION CONVENIENCE KIT CONTAINING GAUZE 4 X 4 8 PLY COMPONENT, CG-1044-8-4 (LOT 2507JK228A). THE LOT MANUFACTURED IN THE COMPLAINT CONVENIENCE KIT LOT WAS SOURCED FROM SUPPLIER, (B)(4). THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Description of Event or Problem

THE CUSTOMER REPORTED ISSUES WITH THE 4 X 4 COTTON GAUZE CONTAINED WITHIN CIRCUMCISION CONVENIENCE KIT MANUFACTURED BY MEDICAL ACTION INDUSTRIES. DURING APPROXIMATELY NINE CIRCUMCISION CASES, SMALL COTTON FIBERS WERE OBSERVED SHEDDING FROM THE GAUZE, REQUIRING ADDITIONAL TIME TO REMOVE THEM TO PREVENT RETENTION AT THE SURGICAL SITE. NO PATIENT INJURIES WERE REPORTED AS A RESULT OF INCIDENTS.