FDA Adverse Event
Malfunction
Summary report: N
BIOPRO, INC.
MDR report key: 252396
·
Received November 30, 1999
Report
- Report Number
- 1832656-1999-00003
- Event Type
- Malfunction
- Date Received
- November 30, 1999
- Date of Event
- July 20, 1999
- Report Date
- November 29, 1999
- Manufacturer
- BIOPRO, INC.
- Product Code
- HSH
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
POLY INSERT WAS REPORTED AS A PRODUCT PROBLEM, REMOVED, AND REPLACED. USER FACILITY REPORT INCLUDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOPRO, INC. Implant | HSH | BIOPRO, INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |