MEMBRAGEL
Received Oct 25, 2012 · Event occurred Nov 24, 2011
Report 1222315-2012-00014 · MDR key 2821024
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
40 YR
- Unspecified Infection
- Inflammation
Narrative
Description of Event or Problem
CLINICIAN REPORTS THAT HE USED MEMBRAGEL TOGETHER WITH PUROS ALLOGRAFT IN AN AUGMENTATION PROCEDURE. THERE WAS A SEVERE INFLAMMATORY RESPONSE. THE TISSUE LOOKED TERRIBLE UNTIL THE REMOVAL OF THE MEMBRANE. 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 PT 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 SPECIFICATION.