FDA Adverse Event
Other
Summary report: N
ZIMMER COLLAGEN PLUG
MDR report key: 3598724
·
Received December 12, 2013
Report
- Report Number
- 2249852-2013-00006
- Event Type
- Other
- Date Received
- December 12, 2013
- Date of Event
- November 6, 2013
- Report Date
- December 5, 2013
- Manufacturer
- COLLAGEN MATRIX, INC.
- Product Code
- KGN
- PMA / PMN Number
- K122115
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD OF EVALUATION - REVIEW OF DEVICE HISTORY RECORD OF THE LOT.
Description of Event or Problem · 1
CUSTOMER REPORTED A CASE WHERE 6 TEETH WERE EXTRACTED. THE COLLAGEN PLUG PRODUCT WAS USED IN ONE OF THE SIX SITES, AND THAT ONE SITE BECAME INFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651313 | ZIMMER COLLAGEN PLUG | COLLAGEN DENTAL WOUND DRESSING | KGN | COLLAGEN MATRIX, INC. | 0102Z | PDWPU13J4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |