InjuryNPK
MEMBRAGEL
Received Jun 30, 2011 · Event occurred Jan 4, 2011
Report 1222315-2011-00025 · MDR key 2153284
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Abscess
- Purulent Discharge
- Unspecified Infection
- Swelling
Narrative
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.
Description of Event or Problem
ON (B)(6) 2010, USE OF MEMBRAGEL, 0.8 ML ARTICLE NUMBER 070.101, BATCH Z5927 AND STRAUMANN BONE CERAMIC, BONE CERAMIC, 0.5-1.0MM, 0.5G, ARTICLE 070.204, BATCH Z0666. CLINICIAN REPORTS ON (B)(6) 2011 AFTER USING MEMBRAGEL AND BONE CERAMIC THE PATIENT HAD SWELLING AND PUS, LOSS OF MEMBRAGEL, ON (B)(6) 2011 SWELLING IS BETTER, ON (B)(6) 2011 EVERYTHING OK. INFECTION WAS TREATED WITH DALACIN AND CHX.