FDA Adverse Event
Malfunction
Summary report: N
0112680-BARD MESH 3 X 6
MDR report key: 395236
·
Received May 8, 2002
Report
- Report Number
- 1213643-2002-00022
- Event Type
- Malfunction
- Date Received
- May 8, 2002
- Date of Event
- April 11, 2002
- Report Date
- May 8, 2002
- Manufacturer
- C.R. BARD, INC.(PUERTO RICO)
- Product Code
- FTL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SURGEON CUT MESH TO FIT AND "FLAKES" FELL INTO PT'S ABDOMEN. MESH RETAINED BY RISK MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 0112680-BARD MESH 3 X 6 | 350101100-MESH FLAT | FTL | C.R. BARD, INC.(PUERTO RICO) | * | 43GLD030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |