BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMBRAGEL

    MDR report key: 2406186 · Received January 6, 2012

    Report

    Report Number
    1222315-2012-00003
    Event Type
    Injury
    Date Received
    January 6, 2012
    Date of Event
    October 12, 2011
    Report Date
    January 6, 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 HAS BEEN CARRIED OUT AND CONFIRMS THAT THE PRODUCT WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    BUCCAL BONE AUGMENTATION ONLY WITHOUT IMPLANTATION ON (B)(6) 2011; REGIO 42 USING BONE CERAMIC AND MEMBRAGEL. PERIO CUT / AREA CLOSURE STRESS-FREE. (B)(6) 2011 CONTROL VISIT: NICE SITUATION / NO PAIN ONLY STRANGE FEELING. (B)(6), 2011: STILL SOME PAIN / NICE HEALING WITHOUT SWELLING / SOME PAIN UNDER PRESSURE / NO LIQUID SECRETION UNDER PRESSURE. (B)(6) 2011 CONTROL VISIT : GINGIVA AREA 43 SOME INFLAMMATION / A LOT OF PLAQUE / CLEANING / NO PUS / REMOVAL OF LITTLE PIECES (MEMBRAGEL?). (B)(6) 2011 CONTROL VISIT: LESS PAIN / PUS WITH AND WITHOUT PRESSURE =>> REMOVAL. (B)(6) 2011 REMOVAL / EMDOGAIN REGIO 42 / A LOT OF PUS / PAINFUL / EXTREME INFLAMMATION / STRONG BLEEDING / REMOVAL MEMBRAGEL AND BONECERAMIC / CLEANING AND RINSED WITH NACL. (B)(6) 2011 NICE WOUND HEALING / SUTURE REMOVAL / SUBSEQUENT TREATMENT OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMBRAGEL PRODUCT CODE NPK - BARRIER MEMBRANE NPK INSTITUT STRAUMANN AG Z5927

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention BONE GRAFTING MATERIAL| BONE CERAMIC: CATALOG # 070.203, LOT Y8039,| EXPIRE DATE 06/30/2015, PRODUCT LYC - SYNTHETIC