FDA Adverse Event
Death
Summary report: N
DAVOL BARD HERNIA MESH 10 X 14 #0112660
MDR report key: 4992702
·
Received August 6, 2015
Report
- Report Number
- MW5055252
- Event Type
- Death
- Date Received
- August 6, 2015
- Date of Event
- June 20, 2011
- Report Date
- August 5, 2015
- Manufacturer
- DAVOL BARD
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 0
DAVOL BARD MESH PLACED DURING (B)(6) 2000, HERNIA REPAIR FAILED IN (B)(6) 2011. SURGERY TO REMOVE MESH WAS COMPLICATED BY MESH ADHERING TO BOWEL AND SURROUNDING ORGANS. REMOVAL OF MESH RESULTED IN PERFORATION TO BOWEL, SEPSIS, AND DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 519851 | DAVOL BARD HERNIA MESH 10 X 14 #0112660 | DAVOL BARD HERNIA MESH 10 X 14 #0112660 | FTL | DAVOL BARD | 0112660 | 43JJA258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 0 | 65 YR | Death | CRESTOR |