FDA Adverse Event Injury Summary report: N

MESH PERFIX LIGHT PLUG MED

MDR report key: 8479712 · Received April 2, 2019

Report

Report Number
MW5085555
Event Type
Injury
Date Received
April 2, 2019
Date of Event
June 27, 2016
Report Date
March 29, 2019
Manufacturer
DAVOL INC., SUB C. R. BARD, INC.
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY SON HAD GOTTEN A RIGHT INGUINAL HERNIA AND SENT IN FOR OPERATION ON (B)(6) 2016. HE HAD A MESH PERFIX LIGHT PLUG - MFR: DAVOL, A DIV., OF BARD, MODEL 0117060, LOT #HUAP0309. MY SON WAS IN SO MUCH PAIN AFTER SURGERY, WHAT WAS SUPPOSE TO BE SAME DAY SURGERY ENDED UP BEING 5 DAYS IN HOSPITAL. THE PAIN STARTED A DAY AFTER HE GOT THE MESH PUT IN. MY SON SWORE THE HERNIA WAS NOT FIXED. HE WAS STILL IN MAJOR PAIN. A FEW MONTHS LATER, I TOOK HIM BACK TO EMERGENCY ROOM BECAUSE OF PAIN AND THE DRS SAID HE HAD A HERNIA AGAIN BUT IT WAS TOO SMALL TO REPAIR IT. MY SON HAS CONSTANT PAIN IN HIS GROIN. HE ALSO HAS RADIATING PAIN WHICH IS IN HIS BELLY BUTTON ACROSS ONE SIDE BY HIS KIDNEY INTO HIS BACK AREA. I HAVE TAKEN HIM TO EMERGENCY ROOM TWO MORE TIMES SINCE THE LAST AND DRS KEEP SAYING THEY CANNOT SEE THE ISSUE AND WHY HE HAS PAIN. THEY HAD SEEN THAT THE HERNIA WAS THERE BUT NO STEPS HAVE BEEN TAKEN TO REPAIR OR CHECK THE STATUS OF THE MESH THAT WAS PLACED IN HIM DURING HIS OPERATION FOR THE INGUINAL HERNIA. MY SON HAS GOOD AND BAD DAYS. BUT WHEN THE PAIN STARTS UP, MY SON IN SO MUCH PAIN THAT IT IS UNBEARABLE. THERE IS TENDERNESS AND SWELLING IN THE AREA. HE HAS THROWN UP AND FELT NAUSEOUS DUE TO THE PAIN. I BELIEVE THIS IS DUE TO THE MESH IMPLANT. MY SON IS ONLY (B)(6). HE WAS IN PERFECT HEALTH BEFORE HE RECEIVED THE MESH IMPLANT IN 2016. DUE TO PAIN IT IS ALSO CAUSING HIM TO GET CHEST PAIN, AND GO INTO PANIC ATTACKS BECAUSE HE IS WORRYING THAT SOMETHING IS WRONG DUE TO AMOUNT OF PAIN HE IS IN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
269729 MESH PERFIX LIGHT PLUG MED MESH, SURGICAL, POLYMERIC FTL DAVOL INC., SUB C. R. BARD, INC. 0117060 HUAP0309

Patients

Seq Age Sex Outcome Treatment
1 16 YR Hospitalization| O