BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH UNKNOWN PRODUCT

    MDR report key: 13565263 · Received February 19, 2022

    Report

    Report Number
    2210968-2022-01201
    Event Type
    Injury
    Date Received
    February 19, 2022
    Date of Event
    May 31, 2021
    Report Date
    April 18, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: INT J ABDOM WALL HERNIA SURG 2021;4:51-7 DOI: 10.4103/IJAWHS.IJAWHS_51_20 PLEASE SEE ARTICLE ATTACHED. 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 (ULTRAPRO MESH AND PROLENE POLYPROPYLENE MESH) 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 INVOLVED? PATIENT DEMOGRAPHICS? EVENT RELATED TO PROLENE MESH DEVICE REPORTED VIA MW # 2210968-2022-01202

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). DATE SENT TO THE FDA: 04/18/2022. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR VIA EMAIL: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? NO. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (ULTRAPRO MESH AND PROLENE POLYPROPYLENE MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? NO. IT IS INVARIABLY THAT A MAJORITY OF PATIENTS WILL DEVELOP PARASTOMAL HERNIA AND ITS ASSOCIATED COMPLICATIONS. THE COMPLICATIONS ARE NOT RELATED TO THE MESHES. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS INVOLVED? NO. PATIENT DEMOGRAPHICS? IT IS AVAILABLE IN THE ARTICLE. PRODUCT COMPLAINT#: (B)(4). DATE SENT TO THE FDA: 04/18/2022. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED INFORMATION: B1, B2, H1: ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THEREFORE, THIS MEDWATCH REPORT WILL BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: LONG-TERM PARASTOMAL HERNIA OCCURRENCE RATE FOLLOWING STAPLED MESH STOMA REINFORCEMENT TECHNIQUE. THIS STUDY AIMS TO : (I) EVALUATE THE LONG-TERM OCCURRENCE RATE OF PARASTOMAL HERNIAS (PSH) WITH STAPLED MESH STOMA REINFORCEMENT TECHNIQUE (SMART) AND ITS ASSOCIATED COMPLICATIONS AND (II) PERFORM RADIOLOGICAL MEASURES OF THE PROGRESSION OF TREPHINE DIAMETER AND AREA. ALL THE PATIENTS THAT UNDERWENT STAPLED MESH STOMA REINFORCEMENT TECHNIQUE (SMART) BETWEEN NOVEMBER 2013 AND JULY 2016 WERE RETROSPECTIVELY REVIEWED. 15 PATIENTS (10 MALES AND 5 FEMALES) WITH MEDIAN AGE OF 76 YEARS (54¿89 YEARS) AND THE MEDIAN ASA WAS 3 (RANGE 2¿3) UNDERWENT ELECTIVE STOMA FORMATION WITH STAPLED MESH STOMA REINFORCEMENT TECHNIQUE (SMART) .DURING SURGERY, THE MESH USED WAS EITHER PARTIALLY ABSORBABLE LIGHTWEIGHT (ULTRAPRO, ETHICON, USA) OR NONABSORBABLE HEAVYWEIGHT POLYPROPYLENE (PROLENE, ETHICON, USA). 14 PATIENTS RECEIVED PARTIALLY ABSORBABLE LIGHTWEIGHT MESH (ULTRAPRO, ETHICON, USA). ONE PATIENT RECEIVED NONABSORBABLE HEAVYWEIGHT POLYPROPYLENE (PROLENE, ETHICON, USA). THE MEAN FOLLOW-UP OF THIS STUDY WAS 28 MONTHS (3¿77 MONTHS). REPORTED COMPLICATION INCLUDED: (N=1) PATIENT WHO DEVELOPED RADIOLOGICAL PARASTOMAL HERNIAS (PSH) AT SOME STAGE DURING THE FOLLOW-UP.(N=?) OF PATIENTS DEVELOPED PARASTOMAL HERNIAS (PSH) BY 1-YEAR FOLLOW-UP . (N=1) ONE MALE PATIENT, DEVELOPED INCARCERATED SMALL BOWEL OBSTRUCTION IN THE PARASTOMAL HERNIAS (PSH) 24 MONTHS LATER. HE REQUIRED AN EMERGENCY LAPAROTOMY WITH COMPLETION COLECTOMY DUE TO PERFORATION, AND SIMULTANEOUS RELOCATION OF THE STOMA. NONE OF THE OTHER PATIENTS REQUIRED SURGICAL INTERVENTION FOR A PARASTOMAL HERNIAS (PSH). IT WAS CONCLUDED, THAT THE DESPITE THE EARLY PROMISE OF STAPLED MESH STOMA REINFORCEMENT TECHNIQUE (SMART) FOR THE PREVENTION OF PARASTOMAL HERNIAS (PSH) , IT DID NOT PREVENT THE OCCURRENCE OF PARASTOMAL HERNIAS (PSH). THE PERFECT TECHNIQUE AND CHOICE OF MESH FOR THE PREVENTION OF PARASTOMAL HERNIAS (PSH) IS STILL AWAITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231600 ULTRAPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention