BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA TISSUE EXPANDER

    MDR report key: 4272076 · Received November 19, 2014

    Report

    Report Number
    2182979-2014-00004
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    July 25, 2014
    Report Date
    November 17, 2014
    Manufacturer
    PMT CORP.
    Product Code
    LCJ
    PMA / PMN Number
    K845036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE RETURN TISSUE EXPANDER TO PMT, AN INVESTIGATION INTO THE CAUSE OF THE LEAK WAS CONDUCTED. THE TISSUE EXPANDER WAS PARTIALLY FILLED AND PLACED UNDER PRESSURE TO DETERMINE IF THERE WAS A LEAK. A LEAK WAS DISCOVERED IN THE REMOTE PORT TUBING, ADJACENT TO THE TUBING CONNECTOR. THE AREA OF THE LEAK WAS PLACED UNDER MAGNIFICATION FOR FURTHER INVESTIGATION. WHILE UNDER MAGNIFICATION, THE EDGE OF THE HOLE IN THE SILICONE TUBE APPEARED TO BE JAGGED AND SIMILAR TO A TEAR. THE HOLE IN THE TISSUE EXPANDER TUBING WHICH CAUSED THE IDENTIFIED LEAK, APPEARS TO HAVE BEEN CREATED FROM EXCESSIVE TENSILE PULLING OF THE TUBING AND/OR WAS DAMAGED BY A SHARP INSTRUMENT DURING THE SUTURING OF THE TUBING CONNECTOR. THIS TYPE OF PRODUCT DAMAGE IS FROM USER ERROR. THERE ARE FOUR POTENTIAL LOT NUMBERS FOR THE PRODUCT IS REPORTED. THE DOCTOR DID NOT PROVIDE US WITH WHICH ONES WERE USED. PMT WAS ABLE TO TRACK THROUGH THE CUSTOMERS ACCOUNT HISTORY THAT THEY ONLY ORDERED THIS PRODUCT TWICE AND THAT THE ORDER DATES CORRESPOND WITH THE SURGERY DATES. THE LOT NUMBERS ARE: LOT 042414, EXP 2018-04D; LOT 050414, EXP 2018-05B; LOT 010512, EXP 2016-01A; LOT 060311, EXP 2015-06E.

    Description of Event or Problem · 1

    ON 10/16/2014, A PMT REP WAS CONTACTED REGARDING AN (B)(6) YR OLD PT THAT WAS LIVING IN (B)(6) AND HAD TWO TISSUE EXPANDERS PLACED INTO HIS SCALP IN (B)(6) ON (B)(6) 2014. AFTER RETURNING HOME TO (B)(6), THE MOTHER CONTACTED THE DOCTOR THREE WEEKS LATER (APPROXIMATELY (B)(6) 2014) TO STATE THE LEFT TISSUE EXPANDER WAS NOT EXPANDING ANYMORE, BUT THE RIGHT ONE WAS. THEY RETURNED TO (B)(6) ON (B)(6) 2014 TO HAVE THE LEFT TISSUE EXPANDER REPLACED. THEY RETURNED HOME TO (B)(6). THREE WEEKS LATER (APPROXIMATELY (B)(6) 2014) THE MOTHER CONTACTED THE DOCTOR IN (B)(6) AGAIN TO STATE THAT THE RIGHT TISSUE EXPANDER WAS CONTINUING TO EXPAND BUT THE LEFT ONE WAS NOT AGAIN. THEY RETURNED TO (B)(6) TO REMOVE BOTH TISSUE EXPANDERS ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748782 INTEGRA TISSUE EXPANDER TISSUE EXPANDER LCJ PMT CORP. 3610-24 042414

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention