BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18564415 · Received January 23, 2024

    Report

    Report Number
    2210968-2024-00605
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    June 10, 2023
    Report Date
    January 23, 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
    NJ, US
    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. CITATION: HTTPS://DOI.ORG/10.1016/J.JHSG.2023.06.010. RELATED EVENTS CAPTURED VIA 2210968-2024-00606 AND 2210968-2024-00607.

    Description of Event or Problem · 0

    TITLE: TRIGGER FINGER RELEASE: ARE SUTURES REQUIRING REMOVAL NECESSARY? THE PURPOSE OF THIS STUDY WAS TO COMPARE THE NUMBER OF POSTOPERATIVE VISITS AND COMPLICATIONS FOLLOWING TRIGGER FINGER RELEASE (TFR) CLOSURE WITH NONABSORBABLE SUTURES VERSUS THOSE FOLLOWING TFR CLOSURE WITH ABSORBABLE SUTURES AND SKIN GLUE. A RETROSPECTIVE REVIEW IDENTIFIED ALL PATIENTS UNDERGOING OPEN TFR OVER A 3-YEAR PERIOD PERFORMED BY TWO HAND SURGERY FELLOWSHIP TRAINED HAND SURGEONS WHO ADHERED TO AN IDENTICAL SURGICAL PROTOCOL EXCEPT FOR INCISIONAL CLOSURE. 278 PATIENTS WERE INCLUDED IN THE STUDY, THE "SUTURE GROUP" CONSISTED OF 142 PATIENTS AND THE "GLUE GROUP" CONSISTED OF 136 PATIENTS. PATIENT WERE DIVIDED INTO TWO COHORTS BASED ON SURGEON PRACTICE. ONE SURGEON CLOSED ALL TFR INCISIONS WITH TWO INTERRUPTED NONABSORBABLE 4-0 POLYPROPYLENE (PROLENE; ETHICON) SUTURES IN A TRANSDERMAL HORIZONTAL MATTRESS FASHION (¿SUTURE¿ GROUP) AND THE OTHER SURGEON CLOSED ALL INCISIONS WITH TWO INTERRUPTED ABSORBABLE 4-0 POLIGLECAPRONE 25 (MONOCRYL; ETHICON) SUTURES IN A SUBDERMAL FASHION, FOLLOWED BY DERMABOND SKIN GLUE (ETHICON). REPORTED COMPLICATION ARE SURGICAL SITE INFECTION, WOUND DEHISCENCE, ASEPTIC DRAINAGE, KELOID SCAR FORMATION, SCAR HYPERSENSITIVITY, PAIN, SWELLING AND ERYTHEMA. IN CONCLUSION, ABSORBABLE SUTURES AFFORD FEWER POSTOPERATIVE VISITS WHILE HAVING A SIMILAR COMPLICATION RATE AS NONABSORBABLE SUTURES REQUIRING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839560 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention