FDA Adverse Event Injury Summary report: N

PERFIX PLUG (LARGE)

MDR report key: 7970032 · Received October 16, 2018

Report

Report Number
MW5080580
Event Type
Injury
Date Received
October 16, 2018
Date of Event
September 1, 2010
Report Date
October 13, 2018
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

Narratives

Description of Event or Problem · 1

WENT IN FOR OPEN, RIGHT INGUINAL, HERNIA REPAIR WITH SUTURE IN (B)(6) 2010. I WAS UNWITTINGLY IMPLANTED WITH THE C. R. BARD-DAVOL "PERFIX PLUG" LARGE SIZE PLUG AND PATCH. I HAD A FOREIGN BODY REACTION, AND MASSIVE PURULENT INFECTION BOTH EXTERNALLY ON SKIN AND INTERNALLY, SEVERE PAIN AND NERVE DAMAGE. THE INFECTION WAS NEVER CURED EVEN AFTER MONTHS AND MONTHS OF HEAVY ANTIBIOTICS, AND EVEN ANTIBIOTIC INFUSION. I WENT SEPTIC AND ALMOST DIED. I STILL GET FLESH EATING BOILS. MY WIFE HAS EXTERNALLY CONTRACTED THE SKIN INFECTION FROM ME. ASIDE FROM THE INFECTION, MY PAIN IS UNTREATABLE. I CAN ONLY GET PARTIAL, TEMPORARY RELIEF FROM NERVE BLOCKS AND GABAPENTIN, BUT THIS DOESN'T REACH ALL MY PAIN CENTERS. EVEN DURING THESE TIMES, MY ACTIVITIES ARE NIL, SO AS NOT TO CAUSE ANY MORE NERVE DAMAGE OR TISSUE DAMAGE. I HAD TO STOP WORKING, FISHING, BICYCLING, AND OMIT EVERY SINGLE OTHER ACTIVITY. I CANNOT WALK THROUGH THE GROCERY STORE OR TAKE MY DOG FOR A WALK. I CANNOT SIT IN ANY TYPE OF CHAIR BESIDES A RECLINER. I CANNOT STAND STRAIGHT UP. THIS NOW AFFECTS MY SEVERE SPINAL ISSUES (BECAUSE OF POSTURE). I HAVE BEEN TOLD I MAY HAVE A RECURRING HERNIA, IMPLYING THE MEDICAL DEVICE MAY ALSO HAVE FAILED AND TORN OR MIGRATED. I COULD WRITE A BOOK ON THIS AS I HAVE BEEN DEALING WITH IT FOR ALMOST A DECADE. BUT I BELIEVE THIS IS THE "JIST" OF IT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
811743 PERFIX PLUG (LARGE) MESH SURGICAL POLYMERIC FTL DAVOL INC. SUB C. R. BARD, INC. 0112770

Patients

Seq Age Sex Outcome Treatment
1 30 YR Hospitalization| L| O| R| S DIAZEPAM| GABAPENTIN| LIDOCAINE OINTMENT| MARCAINE/BUPIVICAINE| STEROID NERVE BLOCK INJECTIONS