BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 1822943 · Received September 1, 2010

    Report

    Report Number
    3005075853-2010-05022
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 12, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE AND PACKAGE WERE RETURNED WITH THE CARTON TORN. THE BLISTER AND DEVICE WERE INSIDE THE CARTON. THE TYVEK LID WAS CRUMPLED UP ON TOP OF BLISTER. THERE WAS EVIDENCE OF SEAL TRANSFER FROM THE TYVEK AROUND ENTIRE CIRCUMFERENCE OF THE BLISTER. THE PACKAGE HAD BEEN COMPLETELY AND CORRECTLY SEALED AT THE PACKAGING FACILITY. IT IS UNKNOWN HOW THE PACKAGE WAS OPENED AND THEN RETURNED TO THE CARTON. BATCH HISTORY RECORDS WERE REVIEWED WITH NO PROTOCOLS, DEFECTS, NON-CONFORMANCES OR QUARANTINE NOTED. THE PRODUCT MET ALL IN- PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE PPH PROCEDURE, THE NURSE STATED THAT THE STERILE PACKAGE WAS OPEN . ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF NOT FEELING WELL, HOT AND COLD FLUSHES, ITCHY HAIR AND SKIN, AND CHEMICAL PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT DEVELOPED CHEMICAL PERITONITIS MANIFESTED BY NOT FEELING WELL, CLOUDY EFFLUENT, MILD REBOUND TENDERNESS, HOT AND COLD FLUSHES, AND ITCHY HAIR AND SKIN. THE PATIENT'S TEMPERATURE WAS 38 DEGREES CELSIUS, BLOOD PRESSURE WAS 139/87 MMHG, AND PULSE WAS 100 BPM. THERE WAS NO GRAM STAIN, AND NO ORGANISM WAS ISOLATED. TREATMENT RENDERED FOR THE EVENT WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER PD THERAPY WAS ONGOING. ON (B)(6) 2010, THE PATIENT RECOVERED FROM THE EVENTS. THE PATIENT'S CONCOMITANT MEDICATIONS INCLUDED LITHIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4T33U

    Patients

    Seq Age Sex Outcome Treatment
    1