FDA Adverse Event
Injury
Summary report: N
HERNIA MESH - POLYPROPYLENE MESH
MDR report key: 7457703
·
Received April 24, 2018
Report
- Report Number
- MW5076694
- Event Type
- Injury
- Date Received
- April 24, 2018
- Date of Event
- July 7, 2015
- Report Date
- April 14, 2018
- Manufacturer
- DAVOL INC., SUB C. R. BARD, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
HAD INGUINAL LAPAROSCOPIC HERNIA SURGERY, MESH INSTALLED BY DR (B)(6). BARD-DAVOL MESH, BARD MESH, CAT # 0112720 POLYPROPYLENE MESH. CONSISTENT RECURRENT PAIN, BOTH PERSISTENT MID LEVEL PAIN, AND RECURRENT VERY INTENSE SHARP NEEDLE PAIN IN THE AREA OF MESH IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295973 | HERNIA MESH - POLYPROPYLENE MESH | MESH, SURGICAL, POLYMERIC | FTL | DAVOL INC., SUB C. R. BARD, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Disability |