FDA Adverse Event
Injury
Summary report: N
MEMBRAGEL
MDR report key: 1661755
·
Received April 16, 2010
Report
- Report Number
- 1222315-2010-00006
- Event Type
- Injury
- Date Received
- April 16, 2010
- Report Date
- April 16, 2010
- Manufacturer
- BIORA AB
- Product Code
- NPK
- PMA / PMN Number
- K082111
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER COMPLETED A REVIEW OF THE MANUFACTURING RECORDS AND FOUND THE PRODUCT TO BE WITHIN SPECIFICATION.
Description of Event or Problem · 1
CLINICIAN REPORTS, THE MEMBRAGEL WAS USED AT THE TIME OF AN IMPLANT PLACEMENT WITH ALLOGRAFT IN A BUCCAL DEHISCENCE WITH FENESTRATION. CLINICIAN REPORTED THAT THE SITE DID NOT HEAL WELL AND INFECTION OCCURRED WITH PIECES OF THE MEMBRAGEL COMING OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEMBRAGEL | BARRIER MEMBRANE | NPK | BIORA AB | MEM913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | AT THE TIME OF MEMBRAGEL USAGE, THE CLINICIAN ALSO| IMPLANT.| USED ALLOGRAFT MATERIAL AND PLACED A DENTAL |