FDA Adverse Event
Malfunction
Summary report: N
DURAMATRIX SUTURABLE
MDR report key: 6307130
·
Received February 7, 2017
Report
- Report Number
- 2249852-2017-00004
- Event Type
- Malfunction
- Date Received
- February 7, 2017
- Date of Event
- January 5, 2017
- Report Date
- February 7, 2017
- Manufacturer
- COLLAGEN MATRIX, INC.
- Product Code
- GXQ
- UDI-DI
- 00813954020419
- PMA / PMN Number
- K141608
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO THE DISTRIBUTOR'S SALES REPRESENTATIVE BY A SURGEON THAT DURAMATRIX SUTURABLE DEVICE WAS USED AS INDICATED AND SUTURED INTO PLACE IN A PROCEDURE. THE SURGEON REVISITED THE SITE 2 WEEKS LATER AND COINCIDENTALLY, NOTICED A 4MM TEAR AT THE CORNER OF THE MEMBRANE THAT NEEDED TO BE REPLACED WITH AN ADDITIONAL DURA MEMBRANE. THE REMAINDER OF THE ORIGINAL MEMBRANE WAS LEFT IN PLACE AND THE PATIENT'S CONDITION WAS REPORTED AS GOOD. THERE WAS NO REPORT OF ANY ADVERSE EVENTS EXPERIENCED BY THE PATIENT AS A RESULT OF THE MEMBRANE TEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 91914 | DURAMATRIX SUTURABLE | COLLAGEN DURA MEMBRANE | GXQ | COLLAGEN MATRIX, INC. | DMS33 | 1609031121 | 00813954020419 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |