BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 12647371 · Received October 18, 2021

    Report

    Report Number
    2210968-2021-09801
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    July 12, 2020
    Report Date
    October 18, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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 ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 1. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCT (PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS OF (B)(6) WOMAN (SUTURE FRAGMENTS LEFT IN THE URINARY TRACT AND ADHESION OF CONCRETIONS) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. 2. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (PROLENE SUTURE) USED IN THIS STUDY? IF YES, PLEASE DESCRIBE. 3. WAS THIS CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION CITE: LEGAL MEDICINE 47 (2020) 101749 HTTPS://DOI.ORG/10.1016/J.LEGALMED.2020.101749 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: RETAINED SURGICAL THREAD AND FORENSIC INVESTIGATION: MALPRACTICE OR COMPLICATION? A (B)(6) WOMAN, SUFFERING FROM LEFT URETEROPELVIC JUNCTION OBSTRUCTION INVOLVING A GRADE III HYDRONEPHROSIS, UNDERWENT ROBOTIC PYELOPLASTY (RP) WITH DOUBLE-J STENT PLACEMENT IN THE RENAL PELVIS. DURING THE THIRD POSTOPERATIVE DAY, THE PATIENT COMPLAINED OF PERSISTENT FLANK PAIN, SO A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED. THE RADIOLOGICAL PROCEDURE REVEALED PERINEPHRIC URINOMA THAT WAS TREATED WITH A PERCUTANEOUS NEPHROSTOMY TO DRAIN THE URINE. IN THE FOLLOWING DAYS, THE PATIENT WAS ASYMPTOMATIC, WITHOUT FEVER, AND THE NEPHROSTOMY TUBE WAS FUNCTIONING WELL. A CT SCAN PERFORMED TWO YEARS LATER DEMONSTRATED AN UNUSUAL LINEAR RIBBON LIKE CALCIFICATION IN THE LEFT RENAL BASIN, WHICH WAS THEN SURGICALLY REMOVED AND DELIVERED TO THE PATIENT. NON-ABSORBABLE MONOFILAMENT THREAD (PROLENE) WAS UTILIZED. REPORTED COMPLICATION INCLUDED PELVIC FINDING WAS A 9 CM LONG FILAMENT COATED IN DISCONTINUOUS CALCIFIED INCRUSTATIONS ON THE SURFACE, IN CONCLUSION ACCORDING TO THE MORPHOLOGICAL CHARACTERISTICS AND THE ELEMENTAL COMPOSITION FOUND IN THE COMPARATIVE ANALYSES, THE FORENSIC PATHOLOGIST CONFIRMED THAT THE ENCRUSTED FINDING WAS CONSISTENT WITH A NON-ABSORBABLE THREAD, PROBABLY PROLENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545240 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention