BEUDAMED
    FDA Adverse Event Death Summary report: N

    COAPTITE

    MDR report key: 728044 · Received June 20, 2006

    Report

    Report Number
    2135225-2006-00008
    Event Type
    Death
    Date Received
    June 20, 2006
    Date of Event
    June 14, 2006
    Report Date
    June 20, 2006
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INITIAL FOLLOW-UP IT WAS LEARNED THAT DR., MEDICAL DIRECTOR AT BOSTON SCIENTIFIC CORP, SPOKE WITH THE TREATING PHYSICIAN. DR SAID HE WAS VERY SURPRISED BY THE DEATH AS THERE WERE NO APPARENT ISSUES DURING THE PROCEDURE THAT WOULD HAVE LED TO THIS OUTCOME. CO'S EVALUATION INDICATES THAT THE DEVICE WAS USED ACCORDING TO LABELED INDICATIONS. THE DEVICE HISTORY RECORDS INDICATE THAT LOTS 1002206 AND 1002346 MET SPECIFICATIONS AT THE TIME OF RELEASE. THERE IS NOT ENOUGH INFO TO DETERMINE CAUSE OF DEATH AT THIS TIME. AN AUTOPSY IS SCHEDULED. THE RESULTS OF WHICH WILL NOT BE AVAILABLE FOR 8 TO 10 WEEKS. MEDICAL DIRECTOR ASKED THE MEDICAL EXAMINER TO INCLUDE AN EVALUATION OF POTENTIAL PRODUCT INTERACTION.

    Description of Event or Problem · 1

    DR REPORTED TO BOSTON SCIENTIFIC (DISTR) THAT A PT HE INJECTED WITH COAPTITE HAS DIED. THE PT WAS INJECTED PERIURETHRALLY WITH 2-3 ML OF COAPTITE. THE PT DIED 8 HRS LATER, BOSTON SCIENTIFIC REPORTED THAT TWO LOTS OF PRODUCT (LOT # 1002206 & 1002346) WERE SHIPPED TO THE PHYSICIAN. IT HAS NOT YET BEEN DETERMINED WHICH LOT MAY HAVE BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM BIOFORM MEDICAL, INC. * 1002206 ANR/OR 1002346

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death NONE REPORTED.