BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUT CHROMIC SUTURE UNKNOWN PRODUCT

    MDR report key: 8383707 · Received March 1, 2019

    Report

    Report Number
    2210968-2019-79190
    Event Type
    Injury
    Date Received
    March 1, 2019
    Report Date
    February 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAL
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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. CITATION: ACADEMIC EMERGENCY MEDICINE. 2004; 11: 730¿735. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: A RANDOMIZED, CONTROLLED TRIAL COMPARING LONG-TERM COSMETIC OUTCOMES OF TRAUMATIC PEDIATRIC LACERATIONS REPAIRED WITH ABSORBABLE PLAIN GUT VERSUS NONABSORBABLE NYLON SUTURES" AUTHORS: HELEN KAROUNIS, MDCM; SERGE GOUIN, MDCM; HARLEY EISMAN, MDCM; DOMINIC CHALUT, MDCM; HELENE PELLETIER, RN, BSC; BRUCE WILLIAMS, MD CITATION: ACADEMIC EMERGENCY MEDICINE. 2004; 11: 730¿735. THE OBJECTIVES OF THE STUDY WAS TO SHOW THAT THE USE OF ABSORBABLE SUTURES IN PEDIATRIC TRAUMATIC LACERATIONS AFFORDS GOOD LONG-TERM COSMESIS AND NO INCREASE IN COMPLICATIONS WHEN COMPARED WITH WOUNDS SUTURED WITH NON-ABSORBABLE SUTURES. THIS WAS A RANDOMIZED CLINICAL TRIAL CONDUCTED IN A PEDIATRIC EMERGENCY DEPARTMENT OF 95 PATIENTS WITH LACERATIONS AND WERE INCLUDED IN THE STUDY. OF WHICH, 50 PATIENTS WERE RANDOMIZED TO GROUP A (20 FEMALE AND 30 MALE PATIENTS; MEDIAN AGE: 8.1 YEARS) AND 45 PATIENTS WERE RANDOMIZED TO GROUP NA (17 FEMALE AND 28 MALE PATIENTS; MEDIAN AGE: 9.5 YEARS). GROUP A PATIENTS RECEIVED ABSORBABLE PLAIN CATGUT SUTURES (ETHICON) AND PATIENTS IN GROUP NA RECEIVED NON-ABSORBABLE NYLON SUTURES (ETHICON). IN GROUP A, REPORTED COMPLICATIONS INCLUDED DEHISCENCE (2%) AND SURGICAL SCAR (N-2) WHICH REQUIRED SURGICAL SCAR REVISION. IN GROUP NA, REPORTED COMPLICATIONS INCLUDED DEHISCENCE (11%), INFECTION (2%), AND SURGICAL SCAR (N-1) WHICH REQUIRED SURGICAL SCAR REVISION. THE STUDY SUGGESTS THAT THE USE OF PLAIN GUT ABSORBABLE SUTURE MATERIAL IN PEDIATRIC TRAUMATIC LACERATIONS AFFORDS GOOD LONG-TERM COSMESIS AND SIMILAR COMPLICATION RATES AS IN TRAUMATIC WOUNDS REPAIRED WITH NONABSORBABLE, NYLON SUTURE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177199 GUT CHROMIC SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, NATURAL GAL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention