BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 9995535 · Received April 24, 2020

    Report

    Report Number
    2210968-2020-03447
    Event Type
    Injury
    Date Received
    April 24, 2020
    Report Date
    April 3, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. 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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PDS II SUTURE, MONOCRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PDS II SUTURE, MONOCRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS CITATION: THER ADV UROL 2018, VOL. 10(11) 351¿355; DOI: 10.1177/1756287218790370. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: OUTCOMES OF ADULT URETHROPLASTY WITH COMMERCIALLY AVAILABLE ACELLULAR MATRIX" AUTHOR(S): AMY MARCIA PEARLMAN, VAIDEHI MUJUMDAR, KARA ELIZABETH MCABEE AND RYAN PATRICK TERLECKI CITATION: THER ADV UROL 2018, VOL. 10(11) 351¿355; DOI: 10.1177/1756287218790370. THE GOAL OF THE PRESENT STUDY IS TO ASSESS SAFETY AND FEASIBILITY OF SUBSTITUTION URETHROPLASTY USING MATRISTEM GRAFT. A TOTAL OF 8 PATIENTS (MEN AGE OF 52 YEARS [33-72 YEARS]) UNDERWENT URETHRAL RECONSTRUCTION WITH EXTRACELLULAR MATRICE (ECM). IN THE PROCEDURE, GRAFTING WAS PERFORMED WITH EITHER ECM ALONE OR IN COMBINATION WITH BMG. 5-0 POLYDIOXANONE (PDS) (ETHICON, INC., SOMERVILLE, NEW JERSEY), 5-0 POLIGLECAPRONE 25 (MONOCRYL) (ETHICON, INC., SOMERVILLE, NEW JERSEY), OR POLYGLACTIN 10 (VICRYL) (ETHICON, INC., SOMERVILLE, NEW JERSEY) SUTURE WAS USED TO APPROXIMATE GRAFT MATERIALS TO THE URETHRAL PLATE, TO OTHER GRAFT MATERIAL, OR TO THE SKIN, AS APPROPRIATE. OF THE PATIENTS COMPLETING SECOND-STAGE REPAIRS, ONE PATIENT HAD URETHROCUTANEOUS FISTULA REQUIRING EXCISION. OUR FINDINGS SUGGEST THAT COMMERCIALLY AVAILABLE ECM CAN BE SUCCESSFULLY USED FOR SUBSTITUTION URETHROPLASTY. IN STAGED REPAIRS, ECM APPEARS TO PERFORM SIMILARLY TO BMG, BUT PATIENTS WITH COMPLEX DISEASE REMAIN AT RISK OF SUBSEQUENT RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461846 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention