FDA Adverse Event
Injury
Summary report: N
MEMBRAGEL
MDR report key: 2153313
·
Received June 30, 2011
Report
- Report Number
- 1222315-2011-00029
- Event Type
- Injury
- Date Received
- June 30, 2011
- Date of Event
- April 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 Y6371 AND STRAUMANN BONE CERAMIC, BONE CERAMIC, BONE CERAMIC, 0.4-0.7MM, 0.25G, ARTICLE 070.203, BATCH Y8040. CLINICIAN REPORTS ON (B)(6) 2011 AFTER USING MEMBRAGEL AND BONE CERAMIC, THE PT HAD SWELLING PUS, LOSS OF MEMBRAGEL, ON (B)(6) 2011, INFECTION WAS TREATED WITH UNKNOWN - EVERYTHING OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEMBRAGEL | BARRIER MEMBRANE | NPK | INSTITUT STRAUMANN AG | Y6371 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |