DURAHESIVE WAFER W/NATURA FLG

Report

• Report Number: 9618003-2015-40065
• Event Type: Injury
• Date Received: December 11, 2015
• Report Date: November 6, 2015
• Manufacturer: CONVATEC DOMINICAN REPUBLIC, INC
• Product Code: EXE
• PMA / PMN Number: EXEMPT
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: IL, US
• Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4) AND PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

Description of Event or Problem · 1

COMPLAINANT REPORTS "RED, BLEEDING SKIN UNDER TAPE BORDER." WE RECOMMENDED USING STOMAHESIVE POWDER AND A WAFER WITHOUT A TAPE BORDER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
820903	DURAHESIVE WAFER W/NATURA FLG	PROTECTOR, OSTOMY	EXE	CONVATEC DOMINICAN REPUBLIC, INC	413162	0K03465

Patients

Seq	Age	Sex	Outcome	Treatment
1				KLONIPIN

Terms

Patient problem · 1

• Tissue Damage

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Source type · 1

• CONSUMER