FDA Adverse Event
Injury
Summary report: N
UNKNOWN MESH
MDR report key: 2182281
·
Received July 23, 2011
Report
- Report Number
- MW5021499
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- November 17, 2009
- Report Date
- July 23, 2011
- Manufacturer
- UNK
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAD TWO HERNIA REPAIRS. ONE WAS SUPPOSED TO HAVE BEEN DONE WITH THE MESH AND NOW THE MESH CANNOT BE FOUND. I HAVE HAD SEVERE PAIN, NOT BEEN ABLE TO EAT, VOMITING. NOW THE SURGEON THAT DID MY SURGERY WILL NOT EVEN SPEAK TO ME OR TRY TO FIX WHATEVER IS WRONG AND MAKING ME SO ILL. HE DID NOT TELL ME IT WOULD CAUSE ME THIS MUCH PAIN AND PROBLEMS. FIRST ONE I DID NOT KNOW WAS DONE. I WENT IN FOR GALL BLADDER SURGERY AND WAS TOLD WHEN I WOKE UP. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN MESH | MESH | FTL | UNK | |||
| 2 | UNKNOWN MESH | MESH | FTL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| O | UNSURE, SURGEON DID NOT EXPLAIN TO ME. |