BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUT CHROMIC SUTURE UNKNOWN PRODUCT

    MDR report key: 8383878 · Received March 1, 2019

    Report

    Report Number
    2210968-2019-79193
    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
    UK
    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. CITATION: BR. J. SURG. VOL. 61 (1974) 313-317. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: THE USE OF DEXON AND PLAIN CATGUT IN CIRCUMCISION". AUTHOR(S): G. L. MOUZAS AND PETER POMPA. CITATION: BR. J. SURG. VOL. 61 (1974) 313-317. THIS STUDY AIMED TO COMPARE THE USE OF DEXON AND PLAIN CATGUT IN CIRCUMCISION. A TOTAL OF 68 MALE PATIENTS (AGED 3 MONTHS TO 56 YEARS) UNDERWENT CIRCUMCISION WITH EITHER DEXON SUTURES (N=37) OR PLAIN CATGUT, ETHICON SUTURES (N=31). POSTOPERATIVELY, OUTCOME IN PLAIN CATGUT SUTURE GROUP INCLUDED TISSUE REACTION COMPRISED OF OEDEMA (N=24) OF WHICH 5 HAD ERYTHEMA; AND INFECTION (N=8) TREATED WITH PENICILLIN THERAPY (N=1) AND ONE RESOLVED WITHOUT TREATMENT; MINOR BLEEDING (N=1) REQUIRING ADDITIONAL SUTURES OF THE APPROPRIATE MATERIAL. CATGUT ABSORBED MORE QUICKLY. THE RELATIVE LACK OF TISSUE REACTION TO DEXON IN COMPARISON WITH CATGUT SUPPORTS THE FINDINGS OF OTHER CLINICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177024 GUT CHROMIC SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, NATURAL GAL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention