BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSYN UD 4/0 18 P-13

    MDR report key: 4233841 · Received November 6, 2014

    Report

    Report Number
    1219930-2014-01020
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 8, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAM
    PMA / PMN Number
    K000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: CUSTOMER REPORTS THAT SUTURE WAS USED FOR WOUND CLOSURE. PATIENT REPORTED THEIR WOUND HAS OPENED IN THE FIRST FEW DAYS FOLLOWING SURGERY AND ARE REQUIRING REPEAT WOUND CLOSURE. THE PATTERN IS OUT OF ORDINARY AS THE SUTURE TYPICALLY DISSOLVES 3-6 WEEKS FOLLOWING THE PROCEDURE. USED ANOTHER DEVICE WITHOUT FURTHER CONSEQUENCE. NO OTHER INFORMATION RELATED TO PATIENT AVAILABLE. NO UNANTICIPATED TISSUE LOSS, TISSUE DAMAGE OR BLEEDING. THE DEVICE IS BEING RETURNED FOR EVALUATION. ADDITIONAL INFORMATION REQUESTED VIA EMAIL. 1. WHAT WAS THE ORIGINAL PROCEDURE? VASECTOMY REVERSAL. 2. HOW MANY DAYS POST-OPERATIVELY DID THE DEHISCENCE OCCUR? PATIENT CONTACTED THE SURGEON VIA CELL PHONE AT DAY 7. 3. HAD THE PATIENT ALREADY BEEN DISCHARGED? YES, SAME DAY. 4. HOW WAS THE WOUND CLOSED AFTER THE DEHISCENCE? (RE-OPERATION IN THE OPERATING ROOM, OUTPATIENT, IN THE OFFICE) PENDING FURTHER DETAILS FROM SURGEON. 5. WHAT WAS USED TO CLOSE THE WOUND AFTER THE DEHISCENCE? PENDING FURTHER DETAILS FROM SURGEON. 6. HOW IS THE PATIENT DOING NOW? PENDING FURTHER DETAILS FROM SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714162 BIOSYN UD 4/0 18 P-13 BIOSYN GAM COVIDIEN, FORMERLY US SURGICAL A DIVISON SM5690 B3L0535X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other