MEMBRAGEL
Received May 23, 2012 · Event occurred Mar 16, 2012
Report 1222315-2012-00005 · MDR key 2589796
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Wound Dehiscence
- Purulent Discharge
- Pain
- Swelling
Narrative
Additional Manufacturer Narrative
THE BATCH RECORD REVIEW WAS CARRIED OUT AT THE MANUFACTURER AND IT CONFIRMS THAT THE PRODUCT WAS WITHIN SPECIFICATION. CATALOG # 070.101, MEMBRAGEL, 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." CATALOG# 070.101, MEMBRAGEL, 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."
Description of Event or Problem
(B)(6) 2012, AT SITE 14 IMPLANTATION WITH AUGMENTATION USING BIO OSS AND BIOGIDE AND MEMBRAGEL 070.101, (B)(4). (B)(6) 2012, SUTURE ABLATION - DEHISCENCE WITH PUS, PAIN AND SWELLING - TREATED WITH ANTIBIOTICS. (B)(6) 2012, PAIN WAS WORSE - REMOVAL OF AUGMENTATE - RINSING WITH CHLORHEXIDINE - NEW SUTURES. (B)(6) 2012, RINSING WITH CHLORHEXIDINE - WOUND WAS NICE AND PT DID NOT HAVE PAIN ANY MORE.