FDA Adverse Event Injury Summary report: N

COOK INC.

MDR report key: 1959841 · Received January 9, 2011

Report

Report Number
MW5018945
Event Type
Injury
Date Received
January 9, 2011
Date of Event
January 10, 2005
Report Date
January 9, 2011
Manufacturer
COOK, INC.
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD OUTPATIENT HERNIA SURGERY IN 2005 AND AFTER 4 YEARS OF MY STOMACH GROWING LARGER AND LARGER, I WAS FINALLY DIAGNOSED WITH FAILURE OF THE MESH USED DURING THAT SURGERY. I HAD TO UNDERGO EXTENSIVE SURGICAL REPAIR WITH HOSPITALIZATION OF ONE WEEK AND ABDOMINAL WALL REPAIR THAT INCLUDED A PLASTIC SURGEON AND GENERAL SURGEON. THE NOTES FROM THE ORIGINAL SURGEON, DR (B)(6), STATED "MESH: SURGISIS GOLD 8-PLY 3X15", MANUFACTURER: COOK INC. 369 LOT # LB247658, MFG CATALOG #: C-SAH-8P-3X15. "PROCEDURE: THERE WAS SOME EVIDENCE OF THE PREVIOUS SURGISIS GOLD MESH THAT HAD TURNED TO SCAR TISSUE BUT THERE WAS A VERY LARGE DEFECT." DURING THE 4 YEARS, AS MY STOMACH GREW LARGER AND LARGER, I ASKED MY GYNECOLOGIST ABOUT THE SIZE OF MY STOMACH. HE STATED IT WAS DUE TO "AGE." THE NEXT YEAR, I ASKED ANOTHER GYNECOLOGIST IN HIS OFFICE AND SHE SHRUGGED HER SHOULDERS. WHEN I WENT FOR MY ANNUAL GYNECOLOGICAL EXAM IN 2009, I ASKED A DIFFERENT GYNECOLOGIST FOR A RECOMMENDATION FOR A PLASTIC SURGEON, SO I COULD HAVE LIPOSUCTION OR A TUMMY TUCK BECAUSE MY STOMACH WAS DISGUSTINGLY LARGE AND SHE'S THE ONE THAT DIAGNOSED THE RECURRENT HERNIA AND THAT I HAD NO STOMACH MUSCLES ACROSS MY ABDOMEN. I THEN WAS REFERRED BACK TO DR (B)(6) AND HE PERFORMED THE NEW SURGERY ON (B)(6) 2009. THERE HAVE BEEN MANY HERNIA MESHES RECALLED BUT I DON'T SEE ANYTHING ABOUT THIS BRAND. PLEASE ADVISE IF OTHERS HAVE EXPERIENCED THIS PRODUCT FAILURE. THANK YOU. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COOK INC. MESH: SURGISIS GOLD 8-PLY 13X15" FTL COOK, INC. LB247658

Patients

Seq Age Sex Outcome Treatment
1 58 YR Hospitalization| O| S