BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION VALVE INLINE, SIPHONGUARD

    MDR report key: 6494229 · Received April 14, 2017

    Report

    Report Number
    1226348-2017-10262
    Event Type
    Injury
    Date Received
    April 14, 2017
    Date of Event
    March 20, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. A SEARCH FOR RELATIVE COMPLAINT FOR THE SAME ISSUE WITH THE SAME PRODUCT CODE AND LOT NUMBER FOR THE LAST YEAR REVEALED THAT THIS IS THE ONLY ISSUE. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3813, WITH LOT CRCC0G, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 14TH APRIL 2014. NO ROOT CAUSE COULD BE DETERMINED AS THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND THE SAMPLE INVESTIGATED. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT IS BOY AND (B)(6), WEIGHT IS (B)(6). HE HAD A SKULL MALFORMATION FOR (B)(6) ABOUT DISEASE HISTORY. THE PATIENT DID ARACHNOID CYST PERITONEAL SHUNT ON (B)(6) 2017, THE OPERATION IS SMOOTH. AFTER THE OPERATION, THE PATIENT HAD A SLOW WOUND HEALING. SEROMA CAN BE FOUND NEAR TO THE HEAD INCISION. AND ON (B)(6) 2017, IT FOUND PATIENT WITH ABDOMINAL BULGE. ACCORDING TO PATIENT'S SITUATION, ANOTHER OPERATION ABOUT VENTRICULO PERITONEAL SHUNT WAS DONE ON (B)(6) 2017. CLEAR LIQUID FLOW FROM THE REMOTE DRAINAGE PUMP. NOW THE PATIENT IS IN THE HOSPITAL FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275231 PRECISION VALVE INLINE, SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CRCC0G

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention