FDA Adverse Event Other Summary report: N

ROUNDY'S 3/4" FLEXIBLE FABRIC BANDAGES

MDR report key: 1033415 · Received February 15, 2008

Report

Report Number: 1038758-2008-00001
Event Type: Other
Date Received: February 15, 2008
Date of Event: October 30, 2007
Report Date: February 13, 2008
Manufacturer: ASO LLC
Product Code: KGX
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

MEDWATCH REPORT INDICATED THAT PRODUCT WAS IN PT'S POSSESSION. MEDWATCH REPORT ALSO DOCUMENTED THAT THE EVENT WAS ABATED AFTER USE OF THE PRODUCT WAS STOPPED. MFR HAS REQUESTED THE PRODUCT TO BE RETURNED FOR FURTHER INVESTIGATION. MFR WILL SUBMIT A FOLLOW UP MDR REPORT TO DOCUMENT INVESTIGATION RESULTS ONCE INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

PT APPLIED ROUNDY'S 3/4" FABRIC BANDAGES TO A BOIL ON RIGHT BUTTOCK FOR 2 DAYS, CHANGING THE BANDAGE ONCE PER DAY. THE GAUZE SECTION OF THE BANDAGE WAS COATED WITH NEOSPORIN. AT THE END OF THE SECOND DAY, A PAINFUL RASH DEVELOPED UNDER THE GLUE SECTION OF THE BANDAGE. PT REPORTED INCIDENT TO FDA. NOTE: MEDWATCH REPORT, DATED 12/18/07 WAS SUBMITTED TO COMPANY AND FORWARDED TO MFR ON 1/31/08 TO RESPOND. DIAGNOSIS OR REASON FOR USE: BOIL ON BUTTOCK EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. PT HAS BEEN CONTACTED TO RETURN PRODUCT FOR INVESTIGATION TO DETERMINE IF THERE WAS AN ADVERSE REACTION OR PRODUCT PROBLEM THAT WARRANTS MDR REPORTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ROUNDY'S 3/4" FLEXIBLE FABRIC BANDAGES	ADHESIVE BANDAGES	KGX	ASO LLC	ROU4005-072-000	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR		Other	NEOSPORIN 2007-2007