InjuryNPK
MEMBRAGEL
Received Jun 30, 2011 · Event occurred Jan 9, 2011
Report 1222315-2011-00023 · MDR key 2153296
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 G9802. CLINICIAN REPORTS ON (B)(6) 2011 AFTER USING MEMBRAGEL AND BONE CERAMIC, THE PT HAD SWELLING; ON (B)(6) 2011, STILL A FISTULA PRESENT; ON (B)(6) 2011, NO SWELLING ANYMORE. INFECTION WAS TREATED WITH DALACIN + CHX.
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.