BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE PIP SZ. 1

    MDR report key: 9209690 · Received October 18, 2019

    Report

    Report Number
    1651501-2019-00043
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Date of Event
    August 12, 2019
    Report Date
    September 23, 2019
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KYJ
    PMA / PMN Number
    K082231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FROM THIS INCIDENT HAS NOT BEEN RETURNED (OR EXPLANTED) TO DATE. HOWEVER, INVESTIGATION PERFORMED AND CONFIRMED THAT UNITS IN LOT 192715T SHOWED SIZE 0 ON THE INNER POUCH LABEL AND SIZE 1 ON THE OUTER POUCH LABEL. REVIEW OF MANUFACTURING RECORDS FOR SPIP-520-1-WW LOT 192715T SHOWED NO EVIDENCE OF A NONCONFORMANCE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE LABELS INCLUDED IN THE DHR SHOW SIZE 1 REFLECTED ON THE INNER POUCH, OUTER POUCH, AND BOX LABELS. THE REPORTED COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT ON (B)(6) 2019, A SILICONE PIP (ID SPIP-520-1-WW ¿ SZE. 1) HAS BEEN IDENTIFIED AS HAVING A POTENTIAL ISSUE WITH LABELING DISCREPANCIES RELATED TO THE SIZE OF THE IMPLANT ON THE LABEL, INDICATING A SIZE 0 WHILE THE OUTER LABELS INDICATED SIZE 1. SINCE THE COMPLAINT WAS ISSUED, ALL UNITS HAVE BEEN REMOVED FROM THE FIELD. NO PATIENT INJURY WAS REPORTED. THE PATIENT, THE FACILITY, AND THE PHYSICIAN HAVE NOT INDICATED ANY TYPE OF DISPLEASURE WITH THE OUTCOME OF THE CASE. PATIENT RECOVERED WELL AS THERE HAS BEEN NO FEEDBACK FROM THE FIELD INDICATING OTHERWISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000660 SILICONE PIP SZ. 1 SILICONE PIP KYJ ASCENSION ORTHOPEDICS 192715T

    Patients

    Seq Age Sex Outcome Treatment
    1