BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7359395 · Received March 21, 2018

    Report

    Report Number
    2210968-2018-71588
    Event Type
    Injury
    Date Received
    March 21, 2018
    Report Date
    March 14, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: JOURNAL OF THE COLLEGE OF PHYSICIANS AND SURGEONS PAKISTAN 2014, VOL. 24 (11): 810-814.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: RANDOMIZED COMPARISON OF POSTOPERATIVE SHORT-TERM AND MID-TERM COMPLICATIONS BETWEEN T-TUBE AND PRIMARY CLOSURE AFTER CBD EXPLORATION" AUTHOR(S): IQBAL MUZAFFAR, PAI ZULA, YUSP YIMIT, AJIM TUERGAN JAAN AND HAO WEN CITATION: JOURNAL OF THE COLLEGE OF PHYSICIANS AND SURGEONS PAKISTAN 2014, VOL. 24 (11): 810-814. THE AIM OF THIS PROSPECTIVE RANDOMIZED TRIAL WAS TO COMPARE THE CLINICAL SHORT-TERM AND MIDTERM COMPLICATIONS OF PRIMARY CLOSURE OF COMMON BILE DUCT (CBD) VERSUS T-TUBE DRAINAGE. FROM AUG2009 TO MAR2013, OUT OF 250 PATIENTS WITH CBD STONES WHO UNDERWENT LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (N=28) AND LAPAROTOMY (N=222), 148 PATIENTS FROM 222 LAPAROTOMIES WERE REQUIRED FOR OPEN CBD EXPLORATION. THESE PATIENTS WERE RANDOMIZED INTO TWO GROUPS: PRIMARY CLOSURE GROUP (N=72) AND T-TUBE DRAINAGE GROUP (N=76). IN PRIMARY CLOSURE GROUP, THE CHOLEDOCHOTOMY WAS CLOSED PRIMARILY WITH INTERRUPTED ABSORBABLE 6.0 VICRYL SUTURES. IN T-TUBE GROUP AFTER TUBE WAS POSITIONED, THE CBD WAS CLOSED USING INTERRUPTED VICRYL (4.0 OR 5.0) SUTURES. IN T-TUBE GROUP, WOUND INFECTION IS PRESENT IN 3 PATIENTS WHICH WERE MANAGED BY ANTIBIOTICS. IN PRIMARY CLOSURE GROUP, 2 PATIENTS HAD WOUND INFECTION. COMPLICATIONS IN PRIMARY GROUP WERE RELATIVELY LOWER THAN THAT IN T-TUBE GROUP BUT THERE WAS NO SIGNIFICANT STATISTICAL DIFFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202077 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention