BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18816096 · Received March 1, 2024

    Report

    Report Number
    2210968-2024-02179
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    February 15, 2022
    Report Date
    March 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-02179, 2210968-2024-02180, AND 2210968-2024-02181 CITATION: UROLOGY ANNALS.VOL 14.112-117. HTTPS://DOI.ORG/10.4103/UA.UA_122_21

    Description of Event or Problem · 0

    TITLE: MODIFIED DOUBLE FACE PREPUTIAL FLAP URETHROPLASTY FOR SINGLE-STAGE REPAIR OF PROXIMAL HYPOSPADIAS. THIS STUDY AIMS TO ASSESS THE OUTCOME OF THE MODIFIED DOUBLE-FACED PREPUTIAL FLAP IN TERMS OF IMPLICATIONS ON COMPLICATION RATES. OUTCOMES ARE STUDIED IN RELATION TO DEMOGRAPHIC FACTORS, THE TYPE OF HYPOSPADIAS, AND CHORDEE APPROACH. FROM 2014 TO 2019 THE MODIFIED PREPUTIAL DOUBLE ONLAY URETHROPLASTY TECHNIQUE WAS USED IN 30 PATIENTS. INITIALLY, A STAY SUTURE IS PLACED IN THE GLANS USING A 5-0 PROLENE STITCH. A SECOND ERECTION TEST WAS DONE FOLLOWING CHORDECTOMY AND IF THERE WAS NO IMPROVEMENT, THEN A DORSAL PLICATION OF THE TUNICA ALBUGINEA WAS DONE USING 5-0 PROLENE SUTURES. THE FLAP IS THEN SUTURED TO THE URETHRAL PLATE USING INTERRUPTED SUTURES WITH A 7-0 POLYDIOXANONE SUTURE (PDS) OVER A 8 FRENCH URETHRAL STENT. WE THEN CONTINUE WITH THE TRADITIONAL APPROACH, IN WHICH THE REMAINING PREPUTIAL SKIN FLAP IS USED AS ANOTHER ONLAY LAYER TO COVER THE VENTRAL SKIN DEFECT USING 5-0 RAPID VICRYL SUTURE. THE REPORTED COMPLICATIONS INCLUDED DIVERTICULA (N=1), GLANULAR DEHISCENCE (N=3), PENILE EDEMA (N=4) AND PROXIMAL URETHROCUTANEOUS FISTULA (N=3). IN CONCLUSION, THE MODIFIED TECHNIQUE USED IN THIS STUDY YIELDED GOOD COSMETIC AND FUNCTIONAL RESULTS. COMPLICATION RATES WERE IN LINE WITH THE LOWER RANGES REPORTED BY THE LITERATURE FOR THE STANDARD DOUBLE ONLAY PREPUTIAL FLAP TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305648 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention