FDA Adverse Event
Injury
Summary report: N
OVITEX REINFORCED BIOSCAFFOLD
MDR report key: 10192611
·
Received June 24, 2020
Report
- Report Number
- 3007321028-2020-00008
- Event Type
- Injury
- Date Received
- June 24, 2020
- Date of Event
- June 4, 2020
- Report Date
- June 25, 2020
- Manufacturer
- AROA BIOSURGERY LTD.
- Product Code
- FTM
- UDI-DI
- 09421904065031
- PMA / PMN Number
- K153632
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE PROBLEM WAS FOUND FROM REVIEW OF THE DHR. THE DEVICES IN ERT-8F03 WERE PRODUCED AS PER ESTABLISHED MANUFACTURING PROCEDURES. ALL PROCESS SPECIFICATIONS WERE MET.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT EXPERIENCED A POTENTIAL "REACTION" TO AN OVITEX P MESH IMPLANTED ON (B)(6) 2019. IT WAS REMOVED ON (B)(6) 2020.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 656210 | OVITEX REINFORCED BIOSCAFFOLD | SURGICAL MESH | FTM | AROA BIOSURGERY LTD. | F10244-1020P | ERT-8F03 | 09421904065031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization |