BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIATAIN SUPER, ADH 10X10

    MDR report key: 5305180 · Received December 16, 2015

    Report

    Report Number
    9610694-2015-00001
    Event Type
    Injury
    Date Received
    December 16, 2015
    Report Date
    December 16, 2015
    Manufacturer
    COLOPLAST A/S
    Product Code
    MGP
    PMA / PMN Number
    K983163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE, SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, PRODUCT DELAMINATION, ALSO SKIN BLISTERED UNDER DRESSING. WE WERE TREATING BOTH PRESSURE SORES WITH HONEY AS A PRIMARY AND BIATAIN AS A SECONDARY DRESSING WHICH WAS MANAGING THE EXUDATE WELL. HIS SKIN CAME OFF WHEN I REMOVED THE DRESSING ON HIS LEFT FOOT AND THE CENTRE OF THE DRESSING HAD STUCK TO HIS SKIN AND HAD COME AWAY FROM THE TOP LAYER . HE MUST HAVE BLISTERED BENEATH THE DRESSING. THE BLISTERED AREAS HAVE NOW HEALED WELL AND WE HAVE NOT APPLIED AN ADHESIVE MATERIAL TO HIS LEGS SINCE. TREATMENT WAS WITH A NON-ADHERENT WOUND CONTACT LAYER AND ABSORBENT PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828932 BIATAIN SUPER, ADH 10X10 DRESSING, WOUND AND BURN, OCCLUSIVE MGP COLOPLAST A/S 0461001006

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| O