FDA Adverse Event
Injury
Summary report: N
MEMBRAGEL
MDR report key: 2153298
·
Received June 30, 2011
Report
- Report Number
- 1222315-2011-00022
- Event Type
- Injury
- Date Received
- June 30, 2011
- Date of Event
- February 7, 2011
- Report Date
- June 30, 2011
- Manufacturer
- INSTITUT STRAUMANN AG
- Product Code
- NPK
- PMA / PMN Number
- K101956
- 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 Y6370. CLINICIAN REPORTS ON (B)(6) 2011 AFTER USING MEMBRAGEL, THE PT HAD BUCCAL SWELLING + FISTULA, LOSS OF MEMBRAGEL. ON (B)(6) 2011, NO SWELLING - EVERYTHING OK. INFECTION WAS TREATED WITH DALACIN + CHX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEMBRAGEL | BARRIER MEMBRANE | NPK | INSTITUT STRAUMANN AG | Y6370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |