BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SPIRAL PDS PLUS

    MDR report key: 6076043 · Received November 3, 2016

    Report

    Report Number
    2210968-2016-14698
    Event Type
    Injury
    Date Received
    November 3, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 14, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WAS THE CONDITION OF THE TISSUE (NORMAL, DISEASED, WEAKENED)? THE DR. SAID THE TISSUE WAS NORMAL TISSUE BUT DID STATE THE PATIENT WAS HEAVY. WAS THERE ANY PATIENT EVENT PRIOR TO THE BLEEDING/ SECOND PROCEDURE (COUGH, FALL)? NO. WAS THIS ROUTINE 2 WEEK POST OP FOLLOW UP VISIT AND ISSUE WAS NOTED? PATIENT CAME BACK ON THE ROUTINE POST OP 10 DAYS AND NOTED THERE WAS SOME BLEEDING. WHAT WAS THE DATE OF THE SECOND PROCEDURE? AFTER THE 10 DAY POST OP VISIT. WHAT WAS PERFORMED TO TREAT THE PATIENT VAGINAL CUFF BLEEDING? THE DR. MADE THE REPAIR VAGINALLY. HE TOOK OUT THE STRATAFIX AND RE-APPROXIMATED THE CUFF. DR. DID STATE HE NOTICED SOME BLEEDING WHERE THE SUTURE PASSED THROUGH THE TISSUE. DID THE STRATAFIX SPIRAL SUTURE PULL THROUGH THE TISSUE? NO. WHAT IS THE SURGEON OPINION REGARDING REACTION TO THE POLYMER? THE SURGEON SAID HE WAS NOT SURE BUT HE SAID IT LOOKED LIKE VASCULITIS. HE STATED SOMETIMES PATIENTS REACT DIFFERENTLY TO DIFFERENT POLYMERS. WHAT ARE THE PATIENT AGE, WEIGHT, PAST MEDICAL AND SURGICAL HISTORY? HE STATED THE PATIENT WAS OVERWEIGHT. WHAT IS THE CURRENT CONDITION OF THE PATIENT? PATIENT NO LONGER HAS BLEEDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON UNKNOWN DATE AND THE BARBED SUTURE WAS USED. TWO WEEKS POST OP, THE PATIENT EXPERIENCED A VAGINAL BLEEDING. DURING EXAMINATION OF CUFF CLOSURE, IT WAS NOTICED THAT THE BARBED SUTURE WAS BROKEN AND THERE WERE AREAS OF BLEEDING. THE DOCTOR WAS UNSURE IF THE PATIENT HAD A REACTION TO THE BARBED SUTURE. IT WAS ALSO REPORTED THAT ADDITIONAL SURGERY TO REPAIR THE BLEEDING VAGINAL CUFF WAS PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726048 STRATAFIX SPIRAL PDS PLUS SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention