FDA Adverse Event
Injury
Summary report: N
MEMBRAGEL
MDR report key: 2143096
·
Received June 23, 2011
Report
- Report Number
- 1222315-2011-00008
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- November 9, 2010
- Report Date
- June 20, 2011
- Manufacturer
- BIORA AB
- Product Code
- NPK
- PMA / PMN Number
- K082111
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2010, USE OF MEMBRAGEL, 0.8 ML ARTICLE NUMBER 070.101, BATCH Y9146 AND STRAUMANN BONE CERAMIC, 0.5-1.0, 0.5G, ARTICLE 070.204 BATCH T9017. CLINICIAN REPORTS ON (B)(6) 2010 AFTER USING MEMBRAGEL AND STRAUMANN BONE CERAMIC THE PT HAD FISTULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEMBRAGEL | BARRIER MEMBRANE | NPK | BIORA AB | Y9146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |