BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH 4150

    MDR report key: 2910022 · Received December 18, 2012

    Report

    Report Number
    2648988-2012-00056
    Event Type
    Injury
    Date Received
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    003229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED ABOUT 2 WEEKS PRIOR TO THE EVENT AND A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS PLACED. THE PT BECAME FEBRILE AND THE PICC WAS REMOVED AND A LEFT INTERNAL JUGULAR (LIJ) 6 FRENCH BARD POWER LINE WAS PLACED TEN DAYS AFTER THE FIRST PICC LINE. THE BIOPATCH WAS USED PER ROUTINE WITH DRESSING CHANGES. THE PT WAS REQUIRING EVERY OTHER DAY DRESSING CHANGES BECAUSE OF SEROSANGUINOUS DRAINAGE AT THE LINE SITE. EIGHT DAYS AFTER, THE LIJ PICC PLACEMENT THE DRESSINGS WAS CHANGED AND THE BIOPATCH WAS NOT USED BECAUSE, THE PT'S SKIN LOCKED EXCORIATED AND THE PT DESCRIBED "BURNING". WHEN THE DRESSING WAS NEXT CHANGED, THE SITE APPEARED NORMAL AND BIOPATCH WAS USED AGAIN. WHEN THE LINE DRESSING WAS CHANGED FOURTEEN DAYS AFTER THE LIJ PICC PLACEMENT, IT WAS REPORTED THAT THE SITE WAS DRAINING GREEN AND YELLOW. THE SITE WAS CLEANED BUT WAS STILL DRAINING. PLASTIC SURGERY CONSULT NOTED THAT THE GREEN AND YELLOW EXUDATE WAS ESCHAR CONSISTENT WITH DEEP SECOND/THIRD DEGREE BURN WOUND. THE BIOPATCH WAS REMOVED, KEPT OFF, AND THE SITE WAS MONITORED. THE SITE DID NOT IMPROVE AND THE LINE WAS CHANGED TO A NEW LOCATION. IT WAS REPORTED THAT BASED ON SEVERAL OBSERVED CASES, PTS WITH CERTAIN SKIN SLOUGHING CONDITIONS WERE AT A HIGH RISK FOR A REACTION CONSISTENT WITH A CHEMICAL BURN ASSOCIATED WITH THE USE OF THE BIOPATCH DEVICE. ADDITIONAL INFO WAS THEN RECEIVED ON (B)(4) 2012 WITH THE FOLLOWING: THE LOT NUMBER OF THE BIOPATCH USED WAS UNK. THE BIOPATCH WAS NOT FROM A KIT. THE FIRST TIME THE BIOPATCH WAS USED ON THE PT WAS AT THE LINE PLACEMENT. THE TYPE OF SKIN PREP THAT WAS USED UNDER THE DRESSING WAS CHLORAPREP (BY POLICY). IT WAS UNK IF THE SKIN PREP WAS ALLOWED TO DRY BUT IT WAS PRESUMED IT WAS IN KEEPING WITH THE POLICY. THE PT DID NOT HAVE INFECTION OF THE SKIN. THE PT WAS BEING TREATED FOR SYSTEMIC INFECTION. THE BIOPATCH WAS IN PLACE NO LONGER THAN 7 DAYS. IT WAS NOT DOCUMENTED HOW MUCH DRAINAGE WAS AT THE INSERTION SITE. THE PT HAS AN ALLERGY TO SULFA. THE APPEARANCE OF THE REACTION WAS REPORTED AS ESCHAR AT SITE OF THE BIOPATCH. THE MEDICAL INTERVENTION THAT WAS PROVIDED WAS THE LINE WAS CHANGED TO A NEW SITE. THE WEIGHT OF THE PT WAS (B)(6). NO PICTURES OF THE REACTION WERE PROVIDED. THE PT REMAINED HOSPITALIZED AND HAS BEEN TRANSFERRED BACK TO SENDING (ACUTE CARE) FACILITY. IT WAS UNK WHAT MAY HAVE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPATCH 4150 NONE FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention