BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7370555 · Received March 26, 2018

    Report

    Report Number
    2210968-2018-71651
    Event Type
    Injury
    Date Received
    March 26, 2018
    Report Date
    March 5, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 03/26/2018. (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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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: OBES SURG. 2013; 23:1571 1574. DOI: 10.1007/S11695-013-0915-1.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: PROPHYLACTIC PREPERITONEAL MESH PLACEMENT IN OPEN BARIATRIC SURGERY: A GUARD AGAINST INCISIONAL HERNIA DEVELOPMENT.¿ AUTHORS: MOHAMMAD HAMDY ABO-RYIA, OSAMA HELMY EL-KHADRAWY, HAMDY SEDKY ABD-ALLAH CITATION: OBES SURG. 2013; 23:1571 1574. DOI: 10.1007/S11695-013-0915-1. THE AIM OF THIS STUDY WAS TO ASSESS THE SAFETY AND EFFICACY OF PREPERITONEAL PROSTHETIC ENFORCEMENT OF MIDLINE INCISIONS DURING OPEN BARIATRIC SURGERY IN PREVENTING INCISIONAL HERNIA DEVELOPMENT. A TOTAL OF 64 MORBIDLY OBESE PATIENTS (51 FEMALES AND 13 MALES; AGE RANGE: 19 TO 60 YEARS OLD) UNDERWENT OPEN BARIATRIC SURGERY. THE PATIENTS WERE RANDOMIZED INTO 2 GROUPS; GROUP 1 UNDERWENT WOUND CLOSURE USING A PROPHYLACTIC PREPERITONEAL POLYPROPYLENE MESH AND GROUP 2 USING THE CONVENTIONAL SUTURE WOUND CLOSURE. DURING CLOSURE IN GROUP 1, THE PERITONEUM IS CLOSED SEPARATELY USING VICRYL 0 SUTURES. A SHEET OF PROLENE MESH ABOUT 4 5 CM LONGER THAN THE WOUND LENGTH AND 10 12 CM WIDTH IS PLACED OVER THE PERITONEUM AND FIXED TO THE UNDERSURFACE OF THE LINEA ALBA ABOVE AND BELOW BOTH ENDS OF THE WOUND AS WELL AS TO THE POSTERIOR RECTUS SHEATH BILATERALLY AT THE LEVEL OF THE MIDDLE OF THE WOUND, THEN THE LINEA ALBA IS CLOSED CONTINUOUSLY USING PROLENE 1 SUTURE TAKING BITES THROUGH THE MESH AT REGULAR INTERVALS ALONG THE WOUND. IN GROUP 2, THE WOUND WAS CLOSED BY MASS CLOSURE OF THE LINEA ALBA USING CONTINUOUS PROLENE 1 SUTURE WITH BITES PLACED 1 CM APART AND 1 CM FROM THE CUT EDGE. IN BOTH GROUPS, A SUBCUTANEOUS CLOSED TUBE DRAIN WAS INSERTED THEN, THE SUBCUTANEOUS TISSUE IS CLOSED WITH INTERRUPTED VICRYL 3-0 SUTURE AND THE SKIN WITH SUBCUTICULAR PROLENE 3-0 SUTURE. IN GROUP 1, THE REPORTED COMPLICATIONS INCLUDED SEROMA (N-6), INFECTION (N-5), PARTIAL WOUND DEHISCENCE (N-1), AND INCISIONAL HERNIA (N-1) WHICH WAS RE-ADMITTED FOR AN OPEN HERNIA REPAIR. IN GROUP 2, THE REPORTED COMPLICATIONS INCLUDED SEROMA (N-5), INFECTION (N-5), PARTIAL WOUND DEHISCENCE (N-2), AND INCISIONAL HERNIA (N-9) WHICH WERE RE-ADMITTED FOR AN OPEN HERNIA REPAIR. IT WAS REPORTED THAT ABDOMINAL WOUND CLOSURE AFTER MIDLINE INCISION IS 1 OF THE MAJOR PROBLEMS IN OPEN BARIATRIC SURGERY. WOUND FAILURE IN THE FORM OF POSTOPERATIVE HERNIA REMAINS A CONSIDERABLE PROBLEM LEADING TO SERIOUS COMPLICATIONS. IT WAS CONCLUDED THAT USING PROPHYLACTIC PREPERITONEAL PROLENE MESH DURING WOUND CLOSURE IN OPEN BARIATRIC SURGERY IS SAFE AND EFFECTIVE IN PREVENTING INCISIONAL HERNIA DEVELOPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213190 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention