BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7654361 · Received July 2, 2018

    Report

    Report Number
    2210968-2018-73971
    Event Type
    Injury
    Date Received
    July 2, 2018
    Report Date
    June 7, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? CITATION: INDIAN J SURG. 2016; 78(5): 371 374. DOI: 10.1007/S12262-016-1484-Z. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: THORACOTOMY FOR TRAUMATIC DIAPHRAGMATIC HERNIA" AUTHOR: ZHANG FANGBIAO, ZHENG CHUNHUI, ZHAO CHUN, SHI HONGCAN, ZHANG XIANGYAN, TU SHAOSONG WEB ADDRESS: DOI 10.1007/S12262-016-1484-Z CITATION: INDIAN J SURG. 2016; 78(5): 371 374. DOI: 10.1007/S12262-016-1484-Z. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO REVIEW THE AUTHORS EXPERIENCE IN THE DIAGNOSIS AND ROLE OF THORACOTOMY FOR TRAUMATIC DIAPHRAGMATIC HERNIA (TDH). BETWEEN JANUARY 2008 AND JUNE 2014, A TOTAL OF 23 PATIENTS (18 MALES AND 5 FEMALES; AGE RANGE: 15 TO 68 YEARS OLD) FROM YANGZHOU MEDICAL COLLEGE (YANGZHOU CHINA) AND LISHUI CENTER HOSPITAL (LISHUI CHINA), WHO UNDERWENT THORACOTOMY FOR TDH, WERE ANALYZED. DURING THE PROCEDURE, ONCE THE DIAGNOSIS OF TDH IS SUSPECTED OR CONFIRMED, THE PATIENTS WERE IMMEDIATELY PREPARED FOR THORACOTOMY DEPENDING ON THE SITE OF INJURY AND IMAGING FEATURES. THE HERNIATED TISSUES AND THE DEFECT IN THE DIAPHRAGM WERE ASSESSED. AFTER THE ABDOMINAL CONTENTS WERE REDUCED THROUGH THE DEFECT, THE DIAPHRAGMATIC DEFECT WAS REPAIRED USING INTERRUPTED PROLENE SUTURES. THE POST-OPERATIVE COMPLICATIONS INCLUDED WOUND INFECTION (N-1, 4.3 %), PNEUMONIA (N-4, 17.4 %), EMPYEMA (N-2, 8.7 %), AND ANEMIA (N-5, 21.7 %). THE FOLLOWING COMPLICATIONS WERE TREATED SUCCESSFULLY. ONE PATIENT DIED DUE TO SERIOUS PNEUMONIA. IT WAS REPORTED THAT THE PREOPERATIVE DIAGNOSIS OF TDH IS STILL A CHALLENGE. ONCE THE DIAGNOSIS OF TDH IS SUSPECTED OR CONFIRMED, THORACOTOMY OR LAPAROTOMY IS REQUIRED IMMEDIATELY. IN THE REPORTED CASES, HERNIATED ABDOMINAL ORGANS WERE PLACED BACK INTO THE ABDOMEN AND THE DEFECT WAS SUCCESSFULLY REPAIRED WITH INTERRUPTED SUTURES VIA A THORACOTOMY. IT WAS CONCLUDED THAT THORACOTOMY OF TDH IS SUCCESSFUL AND EFFECTIVE, BUT SOMETIMES, IT NEEDS AN ADDITIONAL COMPLEX PROCEDURE LIKE ENTERECTOMY OR SPLENECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498806 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention