InjuryNPK
MEMBRAGEL
Received Jun 30, 2011 · Event occurred Jan 17, 2011
Report 1222315-2011-00018 · MDR key 2153303
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Fistula
- Unspecified Infection
- Swelling
Narrative
Description of Event or Problem
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 Y8039. CLINICIAN REPORTS ON (B)(6) 2011 AFTER USING MEMBRAGEL AND STRAUMANN BONE CERAMIC, THE PT HAD BUCCAL SWELLING + FISTULA + LOSS OF MEMBRAGEL. ON (B)(6) 2011, MORE MEMBRAGEL REMOVED. ON (B)(6) 2011, STILL A SMALL BULGE ON THE GINGIVA. INFECTION WAS TREATED UNK.
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.