InjuryNPK
MEMBRAGEL
Received Jun 30, 2011 · Event occurred Sep 27, 2010
Report 1222315-2011-00016 · MDR key 2153310
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- 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 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.
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.