BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROMED (INCLUDED IN CUSTOMED, INC. PACK)

    MDR report key: 2627328 · Received March 1, 2010

    Report

    Report Number
    2648727-2010-00001
    Event Type
    Other
    Date Received
    March 1, 2010
    Date of Event
    February 2, 2010
    Report Date
    February 25, 2010
    Manufacturer
    PROMEDICAL PRODUCTS CO. LTD
    Product Code
    KKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMED, INC RECEIVED FINISHED GOOD CARDIOVASCULAR DRAPE WITH INCISE FROM (B)(6), CATALOG NUMBER 1002052 FOR CARDIOVASCULAR SURGERY. PRODUCT ITEM (B)(4), LOT NUMBER BL-09E1017 WAS INCLUDED IN OPEN HEART PACK CUSTOMED CATALOG NUMBER 900-1196C MANUFACTURED ON AUGUST 2009 AND RELEASED ON SEPTEMBER 2009. THE ITEM IS DESIGNED TO BE USED FOR CARDIOVASCULAR SURGERY AND IT IS USED ONLY FOR TWO (2) CUSTOMED PRODUCTS CATALOG (900-1196C AND 900-170). BOTH CATALOGS ARE OPEN HEART SURGERY. THE END USER CLAIMED THAT PRODUCT ITEM INCISE ADHESIVE WAS STRONG. CUSTOMED INVENTORY WAS ZERO AT THE TIME THAT COMPLAINT WAS NOTIFIED. THERE WAS NO INVENTORY AVAILABLE OF PRODUCT ITEM IMPLICATED LOT OR ANY FINISHED PRODUCT WITH IMPLICATED LOT. THEREFORE, NO INSPECTION COULD BE DONE TO SPECIFIC LOT IMPLICATED. VISUAL INSPECTION WAS PERFORMED TO CARDIOVASCULAR DRAPE INCISE AVAILABLE INVENTORY AT CUSTOMED AGAINST PRODUCT DESIGN AND SPECIFICATIONS AND NO ATYPICAL EVENT WAS FOUND. THE PRODUCT VERIFIED COMPLIED WITH REQUIRED SPECIFICATIONS. THIS INFO HAS BEEN FORWARDED TO THE OEM, PROMEDICAL FOR FURTHER EVALUATION AND FOLLOW UP.

    Description of Event or Problem · 1

    THE CLIENT ALLEGES THAT CARDIOVASCULAR SURGERY DRAPE INCISE HAD STRONG ADHESIVE THAT RESULT IN MINOR LACERATION OF THE SKIN REQUIRING POST OPERATIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMED (INCLUDED IN CUSTOMED, INC. PACK) CARDIOVASCULAR SHEET WITH INCISE KKX PROMEDICAL PRODUCTS CO. LTD NA BL-09E1017

    Patients

    Seq Age Sex Outcome Treatment
    1 Other