BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTEGRA TISSUE EXPANDER

    MDR report key: 2602480 · Received June 5, 2012

    Report

    Report Number
    2182979-2012-00003
    Event Type
    Other
    Date Received
    June 5, 2012
    Report Date
    May 31, 2012
    Manufacturer
    PMT CORP.
    Product Code
    LCJ
    PMA / PMN Number
    K845036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED ON 04/24/2012 WITHOUT ANY IDENTIFIERS ON THE OUTSIDE OF THE PACKAGING, INCLUDED INSIDE THE PACKAGE WAS A LETTER FROM (B)(4) (PMT'S (B)(4) DISTRIBUTOR), STARTING THAT THE PRODUCT LEAKED. ATTACHED TO THE LETTER (B)(4) WAS AN ADDITIONAL LETTER FROM THE USER, BUT IT WAS IN THE (B)(4) LANGUAGE. PMT ATTEMPTED TO HAVE THE DISTRIBUTOR TRANSLATE IT BUT, AS OF 05/22/2012 NO RESPONSE WAS RECEIVED FROM THE DISTRIBUTOR REGARDING A TRANSLATION. PMT TRANSLATED THE LETTER ON THE INTERNET USING "GOOGLE TRANSLATE" TO ENSURE THAT NO POTENTIAL CRITICAL INFO WAS LOCATED IN THE LETTER. THE LETTER STATED THE SAME INFO AS THE ONE FROM THE DISTRIBUTOR. THE PRODUCT RETURNED WAS CONSIDERED A BIOHAZARD AND HELD PENDING DECONTAMINATION UNTIL IT COULD BE DETERMINED IF THE PRODUCT HAD BEEN EXPLANTED. SINCE NO RESPONSE WAS RECEIVED THE PRODUCT WAS TREATED AS THOUGH IT HAD BEEN EXPLANTED AND DECONTAMINATED (ON 05/22/2012) PER PMT PROCEDURE TO ENSURE SAFETY OF PERSONNEL. ON 05/25/2012 THE PRODUCT WAS INVESTIGATED AND A SMALL LEAK WAS DETECTED NEXT TO THE TUBING EXIT AREA OF THE EXPANDER. IT WAS DETERMINED DURING THE INVESTIGATION THAT EXCESSIVE PULL FORCE WAS USED ON THE TUBING CAUSING THE LEAK TO BE CREATED.

    Description of Event or Problem · 1

    PRODUCT WAS SENT BACK FROM A CUSTOMER IN (B)(6), DUE TO A LEAK AT THE TUBING EXIT AREA OF THE EXPANDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA TISSUE EXPANDER INTEGRA TISSUE EXPANDER LCJ PMT CORP. 3614-57 071411

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention