BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PODIATRY PACK (PYPTA)269

    MDR report key: 9708632 · Received February 13, 2020

    Report

    Report Number
    1423537-2020-00414
    Event Type
    Injury
    Date Received
    February 13, 2020
    Date of Event
    December 20, 2019
    Report Date
    February 13, 2020
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    LRO
    UDI-DI
    10887488375717
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED SINCE A WORK-ORDER/LOT NUMBER WAS NOT PROVIDED FOR THE REPORTED INCIDENT. THE SAMPLE FOR THIS REPORTED INCIDENT WAS NOT AVAILABLE FOR FURTHER EVALUATION AND THEREFORE THE EXACT CAUSE COULD NOT BE DETERMINED. AT THIS TIME, NO ADDITIONAL ACTION WILL BE TAKEN, BUT WE WILL CONTINUE TO MONITOR THE TREND FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, ¿WE ARE CURRENTLY TRACKING INFECTION FROM A CASE THAT OCCURRED ON (B)(6) 2019 AND QUALITY ISSUE RELATED TO THE MANUFACTURE OF CERTAIN AAMI LEVEL 3 SURGICAL GOWN.¿ CUSTOMER HAS REPORTED THE PROCEDURE WAS A LEFT FOOT BUNIONECTOMY, OSTEOTOMY OF SECOND AND THIRD METATARSALS, SECOND AND THIRD AND FOURTH ARTHROPLASTY PIJ LEFT FOOT, AND PLANTAR PLATE REPAIR. THE MEDICAL TREATMENT PROVIDED FOR THE INFECTION WAS URGENT CARE VISIT, HOSPITALIZATION, ORAL AND IV ANTIBIOTIC THERAPY, RETURN TO SURGERY FOR I&D, REMOVAL OF IMPLANTS. INSERTION OF PICC LINE BY HOME HEALTH CARE. THE PRESCRIPTIVE MEDICATION FOR THE PATIENT IS PO (ORAL) AUGMENTIN, IV ANTIBIOTICS AS WELL BUT THE EXACT ANTIBIOTIC GIVEN WAS NOT NOTED ON THE PHYSICIAN OFFICE RECORD. AS OF (B)(6) 2020, PATIENT WAS RECEIVING HOME HEALTH CARE AND IV ANTIBIOTICS VIA PICC LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172708 PODIATRY PACK (PYPTA)269 GENERAL SURGERY TRAY (KIT) LRO MEX03 MEXICO-JUAREZ PRESOURCE SOP54PYPTA UNKNOWN 10887488375717

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention