FDA Adverse Event
Injury
Summary report: N
MEMBRAGEL
MDR report key: 2153310
·
Received June 30, 2011
Report
- Report Number
- 1222315-2011-00016
- Event Type
- Injury
- Date Received
- June 30, 2011
- Date of Event
- September 27, 2010
- 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 AND STRAUMANN BONE CERAMIC, 0.4-0.7MM, 0.25G, ARTICLE 070.203 BATCH Y0113. CLINICIAN REPORTS ON (B)(6) 2010 AFTER USING MEMBRAGEL AND STRAUMANN BONE CERAMIC THE PT DID NOT HAVE ANY PAIN BUT MASSIVE SWELLING. INFECTION WAS TREATED UNK.
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 |