FDA Adverse Event Injury Summary report: N

MESH - COMPOSIX KUGEL

MDR report key: 2872003 · Received December 6, 2012

Report

Report Number: 1213643-2012-00849
Event Type: Injury
Date Received: December 6, 2012
Date of Event: December 13, 2011
Report Date: November 16, 2012
Manufacturer: DAVOL INC., SUB. C.R. BARD, INC.
Product Code: FTL
PMA / PMN Number: K061314
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: RI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PT INJURY AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVAL. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN. IF ADD'L EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

Description of Event or Problem · 1

THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: ON (B)(6) 2009, PT HAD OVAL KUGEL PATCH IMPLANTED TO REPAIR AN INCARCERATED VENTRAL HERNIA DEFECT. ON (B)(6) 2011, PT PRESENTED TO THE ER WITH A PARTIAL SMALL BOWEL OBSTRUCTION. HE FAILED TO IMPROVE AND WAS TAKEN TO SURGERY. PT UNDERWENT AN EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, AND EXCISION OF THE KUGEL PATCH. ATTORNEY ALLEGES DEFECTIVE MESH, SMALL BOWEL OBSTRUCTION, PAIN, PERMANENT INJURY, ADD'L SURGERY, ADHESIONS, "PAIN AND SUFFERING," EXPLANT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MESH - COMPOSIX KUGEL		FTL	DAVOL INC., SUB. C.R. BARD, INC.	NA	HUSC1809

Patients

Seq	Age	Sex	Outcome	Treatment
1			Disability