InjuryNPK
MEMBRAGEL
Received Jun 23, 2011 · Event occurred Nov 9, 2010
Report 1222315-2011-00008 · MDR key 2143096
Add to watch list
Product code (NPK)
Manufacturer (Biora Ab)
Model (070.101)
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Fistula
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 Y9146 AND STRAUMANN BONE CERAMIC, 0.5-1.0, 0.5G, ARTICLE 070.204 BATCH T9017. CLINICIAN REPORTS ON (B)(6) 2010 AFTER USING MEMBRAGEL AND STRAUMANN BONE CERAMIC THE PT HAD FISTULA.