FDA Adverse Event Injury Summary report: N

MESH VENTRALEX ST 1.7 IN SM CIR W/STRAP - LOG61086

MDR report key: 4824974 · Received May 29, 2015

Report

Report Number
MW5042934
Event Type
Injury
Date Received
May 29, 2015
Date of Event
June 18, 2013
Report Date
May 29, 2015
Manufacturer
CR BARD MED
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD OPEN VENTRALEX REPAIR OF A VENTRAL HERNIA ON THE PERIUMBILICAL AREA. I HAD BARD VENTRALEX ST MESH 1.7 IN SM CIR WITH STRAP INSERTED INTO MY ABDOMEN AND BENEATH MY NAVEL. EVER SINCE THE INITIAL SURGERY, I HAVE HAD SEVERE PAIN IN THE AREA WHERE THE MESH WAS PUT IN. I HAVE ALWAYS BEEN ABLE TO FEEL THE MESH PUSHING UP ON MY ABDOMEN. A YEAR AFTER MY SURGERY ON (B)(6) 2014, I WENT BACK TO THE SURGEON DUE TO EXTREME PAIN, PRESSURE AND HARD SPOT IN MY NAVEL. THE SURGEON, DR (B)(6), AGREED THAT IT WAS AN ABNORMALITY AND THAT THERE WAS INDEED SOMETHING FIRM PUSHING UP CAUSING SEVERE PAIN. I WAS SENT FOR A MRI. FOLLOWING THE MRI, THE PHYSICIAN ADVISED A CORTISONE SHOT AS HE BELIEVED THE PAIN WAS MESH/MUSCLE INTERFACE RELATED. I RECEIVED A CORTISONE SHOT IN THE AREA WHICH DID NOT REMEDY THE SITUATION. AS TIME GOES ON THE ISSUE CONTINUES TO GET WORSE. MY NAVEL HAS BEEN EXTREMELY TENDER AND PAINFUL TO TOUCH EVER SINCE THE SURGERY. NOW A BULGE HAS FORMED WHERE THE MESH IS AND IS PUSHING UP ON MY ABDOMEN AND NAVEL CAUSING EVEN MORE PAIN AND DISCOMFORT. I CAN FEEL THE MESH EVEN MORE NOW THAN BEFORE AND IT IS EXTREMELY UNCOMFORTABLE. IT HAS BECOME UNBEARABLE TO SIT FOR A LONG PERIOD OF TIME AND ANY KIND OF PHYSICAL ACTIVITY IS OUT OF THE QUESTION. I HAVE HAD TWO PHYSICIANS, DR (B)(6), WHICH ADVISE THE MESH SHOULD BE TAKEN OUT AS SOON AS POSSIBLE AS CLEARLY THERE IS AN ISSUE WITH THE MESS/MUSCLE INTERFACE AS IT HAS GIVEN ME SO MUCH PAIN AND DISCOMFORT. MY PAIN AND DISCOMFORT HAVE NOT ONLY BEEN CONSISTENT BUT PERSISTENT EVER SINCE THE REPAIR WAS COMPLETED. IMPLANT NAME; MESH VENTRALEX ST 1.7 IN SM CIR W/STRAP-LOG61086, INV. ITEM: 15188, MANUFACTURER: CR BARD MED, LOT NO: HUXC1380, LRB: MIDLINE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
351156 MESH VENTRALEX ST 1.7 IN SM CIR W/STRAP - LOG61086 MESH FTL CR BARD MED 15188 HUXC1380

Patients

Seq Age Sex Outcome Treatment
1 21 YR Other| R RX MEDS: BIRTH CONTROL - LEVORA| COCONUT OIL SUPPLEMENT| PROBIOTIC| ONCE A DAY MULTI-VITAMIN| OTC MEDS: VITAMIN C