BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 2240319 · Received September 9, 2011

    Report

    Report Number
    2210968-2011-01260
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ETHICON, INC
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: NARRATIVE - IT WAS REPORTED THAT THE PATIENT WAS GIVEN PREMARIN VAGINAL CREAM 0.5 GM 3 / WEEK.

    Additional Manufacturer Narrative · 1

    (B)(4) - SUTURE SPITTING. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY (B)(6) 2010. THE SURGEON CLOSED THE VAGINAL CUFF WITH SUTURE. THE PATIENT COMPLAINED OF SUTURE IN THE VAGINA AND THE HUSBAND COMPLAINED OF FEELING THE SUTURE DURING INTERCOURSE IN (B)(6) 2010. THE PATIENT WAS UNABLE TO TOLERATE THE SUTURE BEING REMOVED IN THE DOCTOR'S OFFICE. IN (B)(6) 2011. THE PATIENT RETURNED TO SURGERY UNDER ANESTHESIA AND HAD THE SUTURE REMOVED FROM THE VAGINA. THE PATIENT CONTINUES TO HAVE THE SAME COMPLAINTS IN (B)(6) 2011. THE SURGEON IS PLANNING TO TAKE THE PATIENT BACK TO SURGERY SOMETIME IN (B)(6) TO REMOVE MORE SUTURE. THERE WAS NOT ANY INFECTION NOTED AT ANY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention