BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7673303 · Received July 10, 2018

    Report

    Report Number
    2210968-2018-74201
    Event Type
    Injury
    Date Received
    July 10, 2018
    Report Date
    June 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/11/2019.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: HOSPITAL TODAY VOL VI NO 8: AUG2001; 461-464 - (B)(4).

    Additional Manufacturer Narrative · 1

    PC-000214193 DATE SENT TO THE FDA: 07/25/2018 THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : SURGICAL MANAGEMENT OF TYPHOID ENTERIC PERFORATION.(STUDY OF 24 CASES)NODE DISSECTION". AUTHOR : D.N. SAVANT, A.V. DALAI, S.G. PATEL, H.M. BHATHENA, N.M. KAVARANA. CITATION: HOSPITAL TODAY VOL VI NO 8: AUG2001; 461-464. THIS RETROSPECTIVE STUDY AIMED TO PRESENT THE SURGICAL MANAGEMENT FOR PATIENTS WITH TYPHOID ENTERIC PERFORATION. OVER A PERIOD OF 4 YEARS FROM JAN1997 TO DEC2000, 24 PATIENTS (N=20 MALE AND N=4 FEMALE; MEAN AGE OF 34.8 YEARS) UNDERWENT SURGICAL TREATMENT FOR TYPHOID ENTERIC PERFORATION AND THESE PATIENTS WERE DIVIDED ACCORDING TO PERFORATIONS: SOLITARY PERFORATION (N=20) AND MULTIPLE PERFORATION (N=4). IN THE PROCEDURE OF SOLITARY PERFORATION, THE DEFECT WAS SUTURED IN TWO LAYERS USING MERSILK 3.0. POSTOPERATIVELY, COMPLICATIONS IN SOLITARY PERFORATION GROUP INCLUDED ILEUS (N=7), WOUND INFECTION (N=5) AND ABSCESS FORMATION (N=2). PROMPT DIAGNOSIS, AGGRESSIVE FLUID AND ELECTROLYTE RESUSCITATION, ANTIBIOTIC PROPHYLAXIS AND OPTIMAL CHOICE OF THE SURGICAL PROCEDURE BASED ON THE INDIVIDUAL MERITS OF THE CASE CAN ONLY YIELD A POSITIVE OUTCOME KEEPING THE MORBIDITY AND MORTALITY TO A BARE MINIMUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517691 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention