BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIPSTOP US

    MDR report key: 2997683 · Received March 1, 2013

    Report

    Report Number
    2087532-2013-00002
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    May 25, 2012
    Report Date
    January 30, 2013
    Manufacturer
    PLASTO TECHNOLOGIES
    Product Code
    KMF
    PMA / PMN Number
    K982818
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIPSTOP WAS DISCARDED AND NOT AVAILABLE FOR ANALYSIS. REVIEW OF THE COMPLAINT HISTORY RECORDS CONCLUDES THERE ARE NO SIMILAR COMPLAINTS RELATED TO TIPSTOP GLOBALLY EXCEPT THE THREE FROM THIS FACILITY. THE TIPSTOP LABELING STATES "TIPSTOP IS NOT INTENDED AS A LONG-TERM DRESSING. ONCE HEMOSTATICS IS ACHIEVED, TIPSTOP SHOULD BE REMOVED BETWEEN 2 TO 4 HOURS AFTER PLACEMENT". THIS FACILITY INSTRUCTED THE TP TO KEEP THE DRESSING ON FOR 24 HOURS. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    GAMBRO LEARNED THAT FOLLOWING AN ANGIOPLASTY A PT DEVELOPED A BLISTER AT THE SITE OF THE ALGINATE PAD ON OF THE TIPSTOP COMPRESSION DRESSING WITHIN 24 HOURS OF APPLICATION. THE PT WAS INSTRUCTED BY THE FACILITY TO REMOVE THE TIPSTOP DRESSING IN 24 HOURS. ACCORDING TO THE NURSE MGR, THE PT REQUIRED A SURGICAL INTERVENTION TO REMOVE THE SKIN AROUND THE INFECTED AREA. THE TIPSTOP LABELING STATES "TIPSTOP IS NOT INTENDED AS A LONG-TERM DRESSING. ONCE HEMOSTATICS IS ACHIEVED, TIPSTOP SHOULD BE REMOVED BETWEEN 2 TO 4 HOURS AFTER PLACEMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89845 TIPSTOP US KMF PLASTO TECHNOLOGIES TIPSTOP US 2012E140048

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention