BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7700368 · Received July 18, 2018

    Report

    Report Number
    2210968-2018-74502
    Event Type
    Injury
    Date Received
    July 18, 2018
    Report Date
    June 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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: J MED ASSOC THAI 2004; 87(9): 1007-11 - [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CLOSURE VS NON-CLOSURE OF THE VISCERAL AND PARIETAL PERITONEUM AT CESAREAN DELIVERY: 16 YEAR STUDY AUTHOR: WARAPORN WEERAWETWAT, MD; SAYAN BURANAWANICH, MD; MANAT KANAWONG, MD CITATION: J MED ASSOC THAI 2004; 87(9): 1007-11. THE AIM OF THIS PROSPECTIVE RANDOMIZED CONTROLLED TRIAL WAS TO DETERMINE WHETHER NON-CLOSURE OF VISCERAL AND PARIETAL PERITONEUM AT LSCS HAS ADVANTAGES OVER PERITONEAL CLOSURE WITH REGARD TO POSTOPERATIVE COMPLICATION AND ADHESIONS. BETWEEN THE PERIOD OF SEPTEMBER 1, 1987 TO AUGUST 31, 1991; 360 FULL-TERM SINGLE FETUS WERE DELIVERED BY LSCS, WERE INCLUDED IN THE STUDY. THE AUTHORS RANDOMIZED AND SEPARATED THE WOMEN BY RUNNING NUMBER INTO 3 GROUPS. THE VISCERAL AND PARIETAL PERITONEUM WERE LEFT UNCLOSED IN GROUP A. THE PARIETAL PERITONEUM WAS CLOSED IN GROUP B. GROUP C WAS THE CONTROL GROUP WHOSE VISCERAL AND PARIETAL PERITONEUM WERE CLOSED ROUTINELY. DURING THE PROCEDURE, THE UTERINE INCISION WAS CLOSED WITH 2 LAYERS OF CONTINUOUS 1 CHROMIC CAT GUT SUTURE, THE PERITONEUM WITH A CONTINUOUS 000 CHROMIC CAT GUT, AND THE FASCIA WITH A CONTINUOUS 2 POLYGLACTIN SUTURE. THE SKIN WAS APPROXIMATED BY INTERRUPTED 000 PLAIN CAT GUT SUBCUTANEOUS SUTURES, THEN SKIN SUTURE WITH INTERRUPTED 000 MERSILK SUTURES. A URINARY CATHETER WAS ROUTINELY INSERTED THROUGHOUT THE OPERATION AND WAS REMOVED AFTER SKIN CLOSURE. COMPLICATIONS REPORTED WERE: GROUP A: FEBRILE MORBIDITY (N=22), WOUND INFECTION (N=4), ENDOMYOMETRITIS (N=2) AND CYSTITIS (N=9). GROUP B: FEBRILE MORBIDITY (N=19), WOUND INFECTION (N=1), ENDOMYOMETRITIS (N=1), CYSTITIS (N=18) AND PPH (N=1) ON THIRD WEEK. GROUP C: FEBRILE MORBIDITY (N=17), WOUND INFECTION (N=4), CYSTITIS (N=9), PPH (N=1) AND PUERPERAL SEPSIS (N=1) WHICH REQUIRED READMISSION ON THIRD WEEK. THERE WERE 65 OF THE 360 PATIENTS WHO UNDERWENT A SECOND LSCS BETWEEN SEPTEMBER 1988 AND DECEMBER 2003 (20 PATIENTS IN GROUP A, 20 PATIENTS IN GROUP B, AND 25 PATIENTS IN GROUP C). ALL OF THEM HAD NO OTHER ABDOMINAL OPERATIONS BETWEEN THE TWO LSCS. THE SHORTEST INTERVAL PERIOD BETWEEN THE 2 OPERATIONS WAS 1 YEAR, THE LONGEST 11 YEARS. MOST OF THE PATIENTS UNDERWENT THE SECOND LSCS WITHIN 3 TO 5 YEARS. INTRA-ABDOMINAL ADHESIONS FOUND IN SECOND LSCS INCLUDED: MILD ADHESION: GROUP A- (N=1), GROUP B- (N=1); MODERATE ADHESION: GROUP A- (N=2); GROUP B- (N=1); SEVERE ADHESION: GROUP A- (N=1), GROUP B- (N=1) AND GROUP C- (N=3). IN CONCLUSION, THE HYPOTHESIS TESTED WAS THAT NON-CLOSURE OF THE VISCERAL AND PARIETAL PERITONEUM MIGHT BENEFIT THE PATIENTS OF FEWER POSTOPERATIVE COMPLICATIONS AND LESS ADHESION FORMATION. CLOSURE OF VISCERAL AND PARIETAL PERITONEUM SHOWED NO BENEFIT OVER NON-CLOSURE. HOWEVER, ADHESION FORMATION WAS LESS SEVERE IN NON-CLOSURE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543153 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention