FDA Adverse Event
Injury
Summary report: N
MEMBRAGEL
MDR report key: 1910633
·
Received November 19, 2010
Report
- Report Number
- 1222315-2010-00019
- Event Type
- Injury
- Date Received
- November 19, 2010
- Report Date
- November 19, 2010
- Manufacturer
- BIORA AB
- Product Code
- NPK
- PMA / PMN Number
- K082111
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
CLINICIAN REPORTS; IMPLANTS WERE NOT PLACED, AMOUNT OF TIME TO APPEARANCE OF INFECTION IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEMBRAGEL | BARRIER MEMBRANE | NPK | BIORA AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ALLOGRAFT WITH TETRACYDINE |