BEUDAMED
    FDA Adverse Event Other Summary report: N

    PMT INTEGRA TISSUE EXPANDER

    MDR report key: 1706471 · Received May 28, 2010

    Report

    Report Number
    2182979-2010-00002
    Event Type
    Other
    Date Received
    May 28, 2010
    Date of Event
    March 4, 2010
    Report Date
    May 28, 2010
    Manufacturer
    PMT CORP.
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING INITIATED FOLLOWING AN FDA FIELD AUDIT RECOMMENDING A COMPLETE REVIEW OF PAST COMPLAINTS. THIS FILING IS A RESULT OF THAT REVIEW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT COMPLAINED THAT THE TISSUE EXPANDER WAS DEFLATING ON (B)(6) 2010. THE PHYSICIAN EXPLANTED THE DEVICE DUE TO LEAKAGE. NO INFORMATION IF THE PROCEDURE WAS COMPLETED OR IF A REPLACEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PMT INTEGRA TISSUE EXPANDER TISSUE EXPANDER FWM PMT CORP. 3612ES-63-2I 110509

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention