BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CHPV

    MDR report key: 6041561 · Received October 19, 2016

    Report

    Report Number
    1226348-2016-10736
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    June 22, 2016
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IN THE LITERATURE SEARCH ¿SELF-INJECTION OF HOUSEHOLD CLEANING DETERGENTS INTO A VENTRICULOPERITONEAL SHUNT RESERVOIR DURING A SUICIDE ATTEMPT: A CASE REPORT AND LITERATURE REVIEW PUBLISHED ACTA NEUROCHIR DOI 10.1007/S00701-016-2888-Z, IT WAS REPORTED THAT A (B)(6) FEMALE SELF-INJECTED CHEMICALS INTO HER PROGRAMMABLE VALVE IN A SUICIDE ATTEMPT. PER THE ARTICLE: ¿SELF-INJECTION OF HOUSEHOLD CLEANING DETERGENTS (MORE SPECIFICALLY, COMMERCIAL TOILET BOWL CLEANER) INTO THE RESERVOIR OF A VENTRICULOPERITONEAL SHUNT (VPS) HAS NEVER BEEN REPORTED IN THE NEUROSURGICAL LITERATURE. A RIGHT-HANDED (B)(6) FEMALE WITH A PAST MEDICAL HISTORY SIGNIFICANT FOR BIPOLAR DEPRESSION (WITH MULTIPLE PRIOR HOSPITAL ADMISSIONS FOR SUICIDE ATTEMPTS) AND PSEUDOTUMOR CEREBRI (STATUS-POST VPS PLACEMENT FROM A RIGHT FRONTAL APPROACH) SUCCESSFULLY INJECTED ~5 ML OF TOILET BOWL CLEANER INTO HER VENTRICULAR SHUNT RESERVOIR DURING A SUICIDE ATTEMPT¿. SHE WAS TAKEN EMERGENTLY TO THE OPERATING ROOM FOR PLACEMENT OF A LEFT FRONTAL VENTRICULOSTOMY. CEREBROSPINAL FLUID (CSF) SAMPLED INTRAOPERATIVELY SHOWED NUMEROUS GRAM-POSITIVE COCCI (LATER DETERMINED TO BE STAPHYLOCOCCUS EPIDERMIDIS). FOR THIS REASON, HER RIGHT-SIDED SHUNT SYSTEM WAS ALSO REMOVED IN ITS ENTIRETY. SHE WAS TREATED WITH BROAD-SPECTRUM INTRAVENOUS AND INTRAVENTRICULAR ANTIBIOTICS FOR HER BACTERIAL VENTRICULITIS¿ AND SHE WENT ON TO MAKE AN EXCELLENT NEUROLOGICAL RECOVERY.¿ AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690270 UNK CHPV SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention