BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7346085 · Received March 16, 2018

    Report

    Report Number
    2210968-2018-71478
    Event Type
    Injury
    Date Received
    March 16, 2018
    Report Date
    February 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A 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: HERNIA (2013) 17:521¿526; DOI 10.1007/S10029-013-1087-6; PUBLISHED ONLINE: 31 MARCH 2013 - [(B)(4) - STEINEMANN 2013.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: SUTURE REPAIR OF UMBILICAL HERNIA DURING CAESAREAN SECTION: A CASE¿CONTROL STUDY" AUTHORS: D. C. STEINEMANN, P. LIMANI, N. OCHSENBEIN, F. KRA¨HENMANN, P.-A. CLAVIEN, R. ZIMMERMANN, D. HAHNLOSER. CITATION: HERNIA (2013) 17:521¿526; DOI 10.1007/S10029-013-1087-6; PUBLISHED ONLINE: 31 MARCH 2013 THE OBJECTIVE OF THIS RETROSPECTIVE COHORT CONTROL STUDY IS TO INVESTIGATE THE ADDITIONAL BURDENS IN TERMS OF PAIN, PROLONGATION OF SURGERY AND MORBIDITY WHICH IS ADDED TO ELECTIVE CAESAREAN SECTION IF UMBILICAL HERNIA SUTURE REPAIR IS PERFORMED SIMULTANEOUSLY. BETWEEN THE PERIOD OF 2000 AND 2011, 14 PATIENTS, AGES 33 TO 41 YEARS WHO UNDERWENT CAESAREAN SECTION COMBINED WITH UMBILICAL HERNIA REPAIR WERE SELECTED VIA ELECTRONIC CLINICAL INFORMATION SYSTEM. SEVEN PATIENTS UNDERWENT OPEN SUTURE REPAIR (ER) USING SEVERAL INTERRUPTED SUTURES WITH NON-ABSORBABLE MATERIAL (POLYPROPYLENE, 1-0, ETHICON INC., SOMERVILLE, NEW JERSEY, USA) AND SEVEN PATIENTS UNDERWENT INTERNAL RING REPAIR (IR) USING RUNNING ABSORBABLE SUTURE (VICRYL 2-0, ETHICON INC., SOMERVILLE, NEW JERSEY, USA). ALL PATIENTS EXCEPT FOR ONE IN THE ER GROUP WERE OPERATED IN SPINAL ANAESTHESIA. TWO RECURRENCES IN THE IR AND ER SUBGROUP OCCURRED WHO INITIALLY PRESENTED WITH A SMALL HERNIA DEFECT. IN CONCLUSION, DESPITE HIGH RECURRENCE RATE, SIMULTANEOUS UMBILICAL SUTURE REPAIR DURING CAESAREAN SECTION IS WORTH AN ATTEMPT GIVEN THE FACT THAT NO ADDITIONAL PAIN AND MORBIDITY ARE ADDED AND RE-HOSPITALIZATION DAYS FOR SEPARATE HERNIA REPAIR ARE SAVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187090 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention