FDA Adverse Event
Injury
Summary report: N
OVITEX REINFORCED TISSUE MATRIX
MDR report key: 13003967
·
Received December 14, 2021
Report
- Report Number
- 3007321028-2021-00025
- Event Type
- Injury
- Date Received
- December 14, 2021
- Date of Event
- November 29, 2021
- Report Date
- December 15, 2021
- Manufacturer
- AROA BIOSURGERY LTD.
- Product Code
- FTM
- UDI-DI
- 09421904065277
- PMA / PMN Number
- K153633
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
NO DEVICE PROBLEM WAS FOUND FROM REVIEW OF THE DHR. THE DEVICES IN THE SUBJECT LOT WERE PRODUCED AS PER ESTABLISHED MANUFACTURING PROCEDURES. ALL PROCESS SPECIFICATIONS INCLUDING PACKAGE LABELLING REQUIREMENTS WERE MET.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PATIENT EXPERIENCED A PERSISTENT SEROMA AFTER IMPLANTATION OF OVITEX R TO REINFORCE A DIEP FLAP DONOR SITE ON (B)(6) 2021. THE IMPLANTED MATERIAL WAS PARTIALLY REMOVED ON (B)(6) 2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1897749 | OVITEX REINFORCED TISSUE MATRIX | SURGICAL MESH | FTM | AROA BIOSURGERY LTD. | F10254-2020G | ERT-21A02 | 09421904065277 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Female | Hospitalization| R |