BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIPSTOP US

    MDR report key: 3032836 · Received March 1, 2013

    Report

    Report Number
    9615764-2013-00003
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 1, 2012
    Report Date
    January 30, 2013
    Manufacturer
    PLASTO TECHNOLOGIES
    Product Code
    KMF
    PMA / PMN Number
    K982818
    Adverse Event
    Yes
    Report Source
    Manufacturer 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 HEMOSTASIS IS ACHIEVED, TIPSTOP SHOULD BE REMOVED BETWEEN 2 TO 4 HOURS AFTER PLACEMENT." THIS FACILITY INSTRUCTED THE PATIENT TO KEEP THE DRESSING ON FOR 24 HOURS.

    Description of Event or Problem · 1

    GAMBRO LEARNED THAT FOLLOWING AN ANGIOPLASTY, A PATIENT DEVELOPED A BLISTER AT THE SITE OF THE ALGINATE PAD ON OF THE TIPSTOP COMPRESSION DRESSING WITHIN 24 HOURS OF APPLICATION. THE PATIENT WAS INSTRUCTED BY THE FACILITY TO REMOVE THE TIPSTOP DRESSING IN 24 HOURS. THIS EVENT OCCURRED AT THE (B)(6) SITE. ACCORDING TO THE NURSE MANAGER, THE PATIENT REQUIRED A REMOVAL OF HIS GRAFT AND PLACEMENT OF AN ACCESS CATHETER. THE TIPSTOP LABELING STATES "TIPSTOP IS NOT INTENDED AS A LONG-TERM DRESSING. ONCE HEMOSTASIS IS ACHIEVED, TIPSTOP SHOULD BE REMOVED BETWEEN 2 TO 4 HOURS AFTER PLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90148 TIPSTOP US KMF PLASTO TECHNOLOGIES TIPSTOP US 2012E140048

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention