InjuryNPK
MEMBRAGEL
Received Jun 30, 2011 · Event occurred Feb 10, 2011
Report 1222315-2011-00020 · MDR key 2153285
Device
Product problems
- Loss of or Failure to Bond
Patient
Not reported
- Purulent Discharge
- Unspecified Infection
- Pain
- 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, 0.4-0.7MM, 0.25G, ARTICLE 070.204 BATCH Y8042. CLINICIAN REPORTS ON (B)(6) 2011 AFTER USING MEMBRAGEL AND STRAUMANN BONE CERAMIC THE PT HAD PAIN WITH LOSS OF MEMBRAGEL. ON (B)(6) 2011, BUCCAL SWELLING WITH PUS - SLIGHT PAIN. ON (B)(6) 2011, NO SWELLING AND FISTULA ANYMORE - EVERYTHING OK. INFECTION WAS TREATED WITH (B)(6).
Additional Manufacturer Narrative
REVIEW OF BATCH RECORDS INDICATE THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.