MEMBRAGEL
Received Oct 25, 2012 · Event occurred Nov 17, 2011
Report 1222315-2012-00016 · MDR key 2821050
Device
Product problems
- Patient-Device Incompatibility
Patient
43 YR
- Hypersensitivity/Allergic reaction
- Inflammation
- Tissue Damage
Narrative
Description of Event or Problem
CLINICIAN REPORTS THAT HE USED MEMBRAGEL TOGETHER WITH PUROS ALLOGRAFT IN AN AUGMENTATION PROCEDURE. THERE WAS PARTIAL INFLAMED FLAP OVERLYING APT. RECONSTRUCTED WITH PUROS AND MEMBRAGEL. THE CLINICIAN REPORTS THAT THE INFECTED MEMBRANE WAS REMOVED ON (B)(6) 2011.
Additional Manufacturer Narrative
MEMBRAGEL, CATALOG #070.101 PACKAGE INSERT INSTRUCTIONS FOR USE STATE "TREATMENT OUTCOME IS DEPENDENT ON OPERATIVE TECHNIQUE AND PATIENT RESPONSE. AS WITH ANY SURGICAL PROCEDURE, INFECTION IS A RISK. USE STERILE INTRA-OPERATIVE TECHNIQUE. DO NOT USE AT INFECTED SITES". MEMBRAGEL, CATALOG #070.101 PACKAGE INSERT INSTRUCTIONS FOR USE STATE "THE FOLLOWING COMPLICATIONS ARE COMMON WITH THE SURGICAL INTERVENTION WITH BARRIER MEMBRANES AND THEREFORE MAY NOT BE TOTALLY EXCLUDED: SOFT TISSUE DEHISCENCE, HEMATOMA, PAIN, INFLAMMATION, INCREASED SENSITIVITY AND REDNESS." THE MANUFACTURER CARRIED OUT A REVIEW OF THE BATCH RECORD DOCUMENTATION AND CONFIRMS THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATIONS.