BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREPEX

    MDR report key: 6137371 · Received December 1, 2016

    Report

    Report Number
    3011215095-2016-00476
    Event Type
    Death
    Date Received
    December 1, 2016
    Date of Event
    October 2, 2014
    Report Date
    November 30, 2016
    Manufacturer
    CIRC MEDTECH
    Product Code
    HFX
    PMA / PMN Number
    K103695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S AGE AND NAME WAS DIFFERENT AT (B)(6) WHERE HE DIED. DELAYED DEATH NOTIFICATION, WHICH OCCURRED 18 DAYS AFTER HIS DEATH; PATIENT WAS (B)(6). ALTHOUGH PATIENT HAD A GIRLFRIEND,THEY WERE NOT STAYING TOGETHER AND SHE WAS NOT MENTIONED AS THE NEXT OF KIN. NO MENTION/DOCUMENTATION OF SMC WAS MADE AT THE 2 CLINICS THAT FIRST GOT IN CONTACT WITH THE PATIENTS, UNTIL HE GOT TO (B)(6) HOSPITAL. PATIENT'S TRIBE AND RELIGION WERE NOT DOCUMENTED; THESE MAY BE IMPORTANT TO TRACK BEHAVIORAL POST-OP. THIS CASE APPEARS TO HAVE PROTOCOL DEVIATION, HAVING (B)(6) PERSON CIRCUMCISED WITH PREPEX. UNFORTUNATELY NO DOCUMENTATION ON WOUND, ALTHOUGH HE WAS STAYING IN A (B)(6) IN THE PERIPHERALS AND RIDING A (B)(6) WHICH MAY HAVE EXPOSED HIM TO THE RISK OF INJURIES. PREPEX IS NOT USED NOR SOLD IN THE UNITED STATES AND AS A RESULT, THE COMPANY HAS NOT REPORTED EVENTS TO DATE. HOWEVER, THE COMPANY WAS REQUESTED BY THE FDA TO BEGIN REPORTING. AS A RESULT, THERE IS A GAP BETWEEN THE TIME OF THE EVENT AND THE INITIAL REPORT. DEVICE WAS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    PATIENT'S AGE AND NAME WAS DIFFERENT AT (B)(6) WHERE HE DIED: DELAYED DEATH NOTIFICATION, WHICH OCCURRED 18 DAYS AFTER HIS DEATH; PATIENT WAS (B)(6), ON HAART WITH CD4 CELL COUNT OF 600; ALTHOUGH PATIENT HAD A GIRLFRIEND THEY WERE NOT STAYING TOGETHER AND SHE WAS NOT MENTIONED AS THE NEXT OF KIN; NO MENTION/DOCUMENTATION OF SMC WAS MADE AT THE 2 CLINICS THAT FIRST GOT IN CONTACT WITH THE PATIENTS, UNTIL HE GOT TO (B)(6) HOSPITAL; PATIENT'S (B)(6) WERE NOT DOCUMENTED; THESE MAY BE IMPORTANT TO TRACK BEHAVIORAL POST -OP; THIS CASE APPEARS TO HAVE PROTOCOL DEVIATION, HAVING AN HIV+ PERSON CIRCUMCISED WITH PREPEX. UNFORTUNATELY NO DOCUMENTATION ON WOUND, ALTHOUGH HE WAS STAYING IN A (B)(6) WHICH MAY HAVE EXPOSED HIM TO THE RISK OF INJURIES. PREPEX IS NOT USED NOR SOLD IN THE UNITED STATES AND AS A RESULT THE COMPANY HAS NOT REPORTED EVENTS TO DATE. HOWEVER, THE COMPANY WAS REQUESTED BY THE FDA TO BEGIN REPORTING. AS A RESULT THERE IS A GAP BETWEEN THE TIME OF THE EVENT AND THE INITIAL REPORT. THE COMPANY HAS REVISED THE IFU TO INCLUDE WARNINGS REGARDING THE USE OF THE DEVICE IN A POPULATION THAT HAS NOT BEEN PROPERLY IMMUNIZED FOR TETANUS. THE IFU IS ATTACHED WITH THE RELEVANT TEXT HIGHLIGHTED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    PATIENT UNDERWENT PREPEX PLACEMENT ON (B)(6) 2014, HE REQUESTED EARLY REMOVAL ON (B)(6) 2014. SHORTLY AFTER HE WAS ADMITTED TO THE HOSPITAL WITH TETANUS AND DIED ON (B)(6) 2014.

    Description of Event or Problem · 1

    PATIENT UNDERWENT PREPEX PLACEMENT ON (B)(6) 2014, HE REQUESTED EARLY REMOVAL ON (B)(6) 2014. SHORTLY AFTER HE WAS ADMITTED TO THE HOSPITAL WITH TETANUS AND DIED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789194 PREPEX PREPEX HFX CIRC MEDTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death