InjuryNPK
MEMBRAGEL
Received Jun 30, 2011 · Event occurred Apr 7, 2011
Report 1222315-2011-00029 · MDR key 2153313
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Abscess
- Unspecified Infection
- Swelling
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.