BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDSII VIO 96IN 1 S/A XLH LP

    MDR report key: 7542949 · Received May 24, 2018

    Report

    Report Number
    2210968-2018-73052
    Event Type
    Injury
    Date Received
    May 24, 2018
    Report Date
    May 1, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031061927
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. 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 NAME OF THE PROCEDURE? WHAT WAS THE DATE OF THE INITIAL PROCEDURE? WHAT TISSUE LAYER WAS THE PDS SUTURE USED ON? WHAT WAS THE CONDITION OF THE TISSUE (NORMAL, DISEASED, WEAK)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS TECHNIQUE)? WHAT IS MEANT BY ¿WOUND DEHISCENCE¿? WHAT DATE DID THE PATIENT PRESENT WITH SYMPTOMS OF WOUND OPENING? WAS A SECOND PROCEDURE PERFORMED TO TREAT THE DEHISCENCE? WHAT WAS THE DATE (POST OP) FOR THE SECOND PROCEDURE? CAN YOU DESCRIBE THE APPEARANCE OF THE PDS DURING SECOND PROCEDURE? WERE THE KNOTS INTACT AND THE SUTURE BROKEN? WAS THE SUTURE INTACT AND PULLED AWAY FROM THE TISSUE? WHAT ARE THE PATIENT AGE, GENDER, WEIGHT AND MEDICAL HISTORY? DO YOU HAVE ANY SUTURE SAMPLES OF Z881G LOT LMZ625 FOR EVALUATION? WHAT IS THE CURRENT CONDITION OF THE PATIENT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED WOUND CLOSURE DEHISCENCE. THE PATIENT WAS RETURNED TO THE OR FOR ADDITIONAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383673 PDSII VIO 96IN 1 S/A XLH LP SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. LMZ625 10705031061927

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention