BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBRAGEL

    MDR report key: 2589796 · Received May 23, 2012

    Report

    Report Number
    1222315-2012-00005
    Event Type
    Injury
    Date Received
    May 23, 2012
    Date of Event
    March 16, 2012
    Report Date
    May 23, 2012
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    NPK
    PMA / PMN Number
    K101956
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMBRAGEL BARRIER MEMBRANE NPK INSTITUT STRAUMANN AG AP732

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BIO OSS| BIO GIDE