BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH PAPETTE CERVICAL CELL SAMPLER

    MDR report key: 981156 · Received August 14, 2007

    Report

    Report Number
    1219739-2007-00003
    Event Type
    Malfunction
    Date Received
    August 14, 2007
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Product Code
    HHT
    PMA / PMN Number
    k896065
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR PAPETTES OF THIS LOT # FROM THIS OR ANY OTHER SOURCE. PAPETTES ARE SUPPLIED IN 25 COUNT BAGS. ONLY ONE SAMPLE FROM THE LOT THAT THE PHYSICIAN RETURNED AND HAD IDENTIFIED SHOWED SIGNS OF DAMAGE. THE DAMAGE IS NOT CONSISTENT WITH DEFICIENCIES KNOWN TO OCCUR DURING THE MANUFACTURE OF THE PRODUCT. HOWEVER, IT IS NOT CONCLUDED THAT THIS DAMAGE IS A CONTRIBUTING FACTOR. HANDLING AND STORAGE CONDITIONS CANNOT BE DETERMINED AT THIS TIME. THE ONE IDENTIFIED PAPETTE WAS PULL TESTED FOR STRENGTH OF SEPARATION. A LOW SEPARATION STRENGTH WAS FOUND, WHICH IS CONSISTENT WITH THAT OF A BRUSH THAT HAS BEEN REMOVED AND REASSEMBLED ON ITS HANDLE. THE INCIDENT WAS A RARE OCCURRENCE OUT OF 16 MILLION PAPETTE SOLD IN ONE YEAR. NO FURTHER ACTION/CORRECTIVE ACTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLACH PAPETTE CERVICAL CELL SAMPLER PAP SMEAR BRUSH HHT WALLACH SURGICAL DEVICES, INC. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 Other