BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY HC LINER 28/DME

    MDR report key: 4959798 · Received July 30, 2015

    Report

    Report Number
    3005180920-2015-00163
    Event Type
    Injury
    Date Received
    July 30, 2015
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 135629: (B)(4) LINERS MANUFACTURED AND RELEASED ON 01/16/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) LINES OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. LOT 140238: (B)(4) HEADS MANUFACTURED AND RELEASED ON 04/17/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) HEADS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 07/30/2015 IT WAS COMMUNICATED THAT NO ADDITIONAL INFORMATION ABOUT (B)(4) WAS RECEIVED YET.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495669 DOUBLE MOBILITY HC LINER 28/DME HC PE DOUBLE MOBILITY LINER MEH

    Patients

    Seq Age Sex Outcome Treatment
    1