MEMBRAGEL
Received Oct 25, 2012 · Event occurred Dec 20, 2011
Report 1222315-2012-00015 · MDR key 2821051
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
59 YR
- Unspecified Infection
- Pain
Narrative
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.
Description of Event or Problem
CLINICIAN REPORTS THAT HE USED MEMBRAGEL TOGETHER WITH PUROS ALLOGRAFT IN AN AUGMENTATION PROCEDURE. THERE WAS A PAINFUL FLAP OVERLYING THE RECONSTRUCTION SITE, ALSO FLAP INDURATION AND MATERIAL REMOVED MUCOSA RETURNED TO NORMAL. THE CLINICIAN REPORTS THAT THE INFECTED MEMBRANE WHICH WAS PLACED ON (B)(6) 2011 WAS REMOVED ON (B)(6) 2011.