BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL UND 70CM 2-0 KS

    MDR report key: 8224130 · Received January 7, 2019

    Report

    Report Number
    2210968-2019-78246
    Event Type
    Injury
    Date Received
    January 7, 2019
    Report Date
    December 18, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K964072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS MEDWATCH REPORT IS BEING VOIDED AS IT IS A DUPLICATE OF MEDWATCH REPORT # 2210968-2019-78232. PLEASE SEE MEDWATCH REPORT # 2210968-2019-78232 FOR ALL INFORMATION REGARDING THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT WAS THE DATE OF THE INITIAL PROCEDURE? HOW WAS THE W3651 MONOCRYL SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? WHAT TISSUE LAYER WAS THE MONOCRYL SUTURE USED ON? WAS THERE ANY PATIENT EVENT PRIOR TO THE WOUND DEHISCENCE (COUGH, FALL, ETC)? CAN YOU DESCRIBE THE APPEARANCE OF THE MONOCRYL SUTURE DURING THE SECOND PROCEDURE? WAS THE SUTURE INTACT AND PULLED AWAY FROM THE TISSUE? WAS THE SUTURE FOUND BROKEN, IF SO, CAN YOU DESCRIBE WHERE (END, MIDDLE, KNOT)? WHAT WAS USED FOR RE-SUTURING? WHAT IS THE SURGEON¿S OPINION AS TO THE POTENTIAL CONCERN REGARDING THE MONOCRYL SUTURE? WHAT ARE THE PATIENT AGE, WEIGHT, MEDICAL HISTORY? WHAT IS THE CURRENT CONDITION OF THE PATIENT? CAN YOU IDENTIFY THE LOT NUMBER OF THE W3651 SUTURE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT CAESAREAN SECTION PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2018 AND SUTURE WAS USED. THE PATIENT EXPERIENCED WOUND DEHISCENCE 2 DAYS POST PROCEDURE WITH BOWEL SEEN UNDER THE SKIN. THE RECTUS SHEATH WAS OPEN- BURST ABDOMEN. AN ADDITIONAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE FOR RE SUTURING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17029 MONOCRYL UND 70CM 2-0 KS SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention