InjuryNPK
MEMBRAGEL
Received Jun 30, 2011 · Event occurred Jan 21, 2011
Report 1222315-2011-00014 · MDR key 2153308
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Abscess
- Purulent Discharge
- 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, 0.4-0.7MM, 0.25G, ARTICLE 070.203 BATCH Y8040. CLINICIAN REPORTS ON (B)(6) 2011, AFTER USING MEMBRAGEL AND STRAUMANN BONE CERAMIC, THE PT HAD SWELLING AND PUS. INFECTION WAS TREATED WITH UNKNOWN.
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.