BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXON 1 GR 96 GS-26 LOOP

    MDR report key: 4109300 · Received September 23, 2014

    Report

    Report Number
    1219930-2014-00832
    Event Type
    Death
    Date Received
    September 23, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 26, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAM
    PMA / PMN Number
    K990951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PLEASE REFER TO PAGE 3 FOR THE FULL EVENT DESCRIPTION. PROCEDURE: LAPAROTOMY. ACCORDING TO THE REPORTER: POST OPERATIVE DAY 2, THE PATIENT WAS IN THE SURGICAL ICU AND WAS EXPERIENCING DIFFICULTY BREATHING AND HAD SEVERE COUGHING BOUT AND SAT UPWARDS AND FORWARDS. APPARENTLY THE PATIENT EXPERIENCED SEVER PAIN IN THE ABDOMEN AND APPARENTLY THE MAXON SUTURE TORE OFF FROM THE TISSUE AS THE PATIENT'S ENTIRE ABDOMEN EXPANDED AND THE DOCTOR PRESUMED THE INTESTINES EXPOSED. PATIENT'S CONDITION WAS CRITICAL AND UNSTABLE AND WAS UNABLE TO AT THIS STAGE RE-DO SURGERY WHICH HE PASSED ON THE FOLLOWING DAY. CLARIFICATION, PATIENT EXPIRED ON THE FOLLOWING DAY. THE BLOOD LOSS WAS LESS THAN 500CC, PART OF THE INSTRUMENT BROKE INSIDE THE PATIENT AND THE WAS UNANTICIPATED TISSUE LOSS AS A RESULT OF THE PROBLEM. ADDITIONAL INFORMATION REQUESTED VIA EMAIL. WHAT WAS THE PATIENT PRE-OPERATIVE DIAGNOSIS? WHAT WAS THE PATIENT'S DRUG REGIMEN ? WHAT WAS THE DATE OF THE SURGERY? CAN YOU PROVIDE A COPY OF THE OPERATIVE REPORT? WHAT IS THE SPECIFIC PRODUCT ALLEGED TO BE ASSOCIATED TO THIS EVENT? WHAT ARE THE PRODUCT LOT NUMBERS? WAS PRODUCT RE-STERILIZED PRIOR TO USE? WHAT IS THE FULL NAME + TILE OF PERSON WHO REPORTED THE INCIDENT TO YOU? WHAT WAS THE PATIENT AGE, GENDER AND WEIGHT? CAN YOU REPORT OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS (E.G., ALLERGIES, RACE, PREGNANCY, SMOKING AND ALCOHOL USE, HEPATIC/RENAL DYSFUNCTION, ETC.)? CAN YOU REPORT PATIENT RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES? WHAT WAS THE DATE OF DEATH? CAN YOU PROVIDE A COPY OF THE AUTOPSY REPORT? IS THERE ANY EVALUATION OF THE EVENT BY THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE, OR HEALTHCARE PROFESSIONAL? ON THE FORM, IT IS INDICATED THAT THE PRODUCT WAS RE-STERILIZED. CAN YOU CONFIRM THIS IS THE CASE, OR WAS THAT A TYPO? IT IS UNUSUAL FOR US TO RECEIVE STERILE SUTURE SAMPLES. IT WAS AN ERROR, THE SUTURES WERE NOT RESTERILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591643 MAXON 1 GR 96 GS-26 LOOP MAXON GAM COVIDIEN, FORMERLY US SURGICAL A DIVISON B4B0752X

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death