BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 6643126 · Received June 15, 2017

    Report

    Report Number
    2210968-2017-32553
    Event Type
    Injury
    Date Received
    June 15, 2017
    Date of Event
    April 19, 2017
    Report Date
    April 20, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4. THE REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: YOU REPORTED THAT THE SUTURE FAILED. HOW EXACTLY DID THE SUTURE FAIL? THE SUTURE WAS BROKEN SO THERE WAS A DEHISCENCE. IF REOPERATION WAS PERFORMED ON (B)(6), PLEASE PROVIDE DATE, WHAT TYPE OF PROCEDURE AND SURGICAL FINDINGS? ABDOMINAL HYSTERECTOMY WAS THE ORIGINAL PROCEDURE. REOPERATION TO CLOSE THE WOUND. HOW IS THE PATIENT TODAY? DNK. ATTEMPTS ARE BEING MADE TO OBTAIN MORE ADDITIONAL FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WHAT WERE CURRENT SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? WHAT TISSUE TYPE AND LOCATION OF THE SUTURE PLACEMENT? WHAT TISSUE DEHISCED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? WHAT WAS THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE? WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT. WHAT IS THE PATIENT CURRENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY ON UNKNOWN DATE AND THE SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE SUTURE BROKE AND THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT UNDERWENT A RE-OPERATION ON (B)(6)2017. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425192 PDS II (POLYDIOXANONE) SUTURE SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK KJZ069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention