FDA Adverse Event
Injury
Summary report: N
BARD MESH
MDR report key: 10401042
·
Received August 12, 2020
Report
- Report Number
- MW5096057
- Event Type
- Injury
- Date Received
- August 12, 2020
- Date of Event
- January 1, 2018
- Report Date
- August 11, 2020
- Manufacturer
- BARD / DAVOL INC., SUB. C. R. BARD, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
CHRONIC MESH INFECTION, CHRONIC OPEN WOUND FROM 10" X 14" BARD MESH. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 864304 | BARD MESH | MESH, SURGICAL, POLYMERIC | FTL | BARD / DAVOL INC., SUB. C. R. BARD, INC. | HUBQ2586 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other| S |