InjuryNPK
MEMBRAGEL
Received Jun 30, 2011 · Event occurred Feb 24, 2011
Report 1222315-2011-00027 · MDR key 2153282
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Purulent Discharge
- Fistula
- Unspecified Infection
- Swelling
Narrative
Description of Event or Problem
ON (B)(6) 2011, USE OF MEMBRAGEL, 0.8 ML ARTICLE NUMBER 070.101, BATCH Z5927 AND STRAUMANN BONE CERAMIC, BONE CERAMIC, BONE CERAMIC, 0.4-0.7MM, 0.25G, ARTICLE 070.203, BATCH Z0668. CLINICIAN REPORTS ON (B)(6) 2011 AFTER USING MEMBRAGEL AND BONE CERAMIC THE PATIENT HAD SWELLING AND FISTULA AND PUS, ON (B)(6) 2011 STILL PUS. INFECTION WAS TREATED WITH DALACIN AND CHX.
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.