BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROGRIP MESH PRODUCT

    MDR report key: 4590933 · Received March 11, 2015

    Report

    Report Number
    9615742-2015-00013
    Event Type
    Injury
    Date Received
    March 11, 2015
    Report Date
    March 2, 2015
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON 03/11/2015.

    Description of Event or Problem · 1

    BACKGROUND : THE LICHTENSTEIN REPAIR IS A WELL STANDARDIZED SURGICAL TECHNIQUE THAT CAN MOSTLY BE PERFORMED IN DAY-CLINIC UNDER LOCO-REGIONAL ANESTHESIA. THE MAJOR CONCERN IS THE CHRONIC PAIN REPORTED AFTER MESH SUTURE FIXATION. WE STUDIED THE PRACTICAL AND CLINICAL ASPECTS OF A LICHTENSTEIN REPAIR USING THE SEMI-RESORBABLE SELF-FIXATING PARIETEX PROGRIP MESH. METHODS : CONSECUTIVE PATIENTS WITH INGUINAL HERNIA WERE OPERATED ACCORDING TO THE LICHTENSTEIN TECHNIQUE USING PARIETEX PROGRIP {SUP}{/SUP}. COMPLICATIONS WERE ASSESSED. PAIN AND DISCOMFORT WERE EVALUATED AT DISCHARGE, AND AT 1 AND 4 WEEKS AND MINIMUM 6 MONTHS AFTER THE INTERVENTION. RESULTS : 320 PATIENTS WERE INCLUDED IN THE STUDY. NO INTRA-OPERATIVE COMPLICATIONS OR DIFFICULTIES OCCURRED. MEAN OPERATING TIME WAS 36 MINUTES (RANGE 20-65 MINUTES). 87.5% OF THE PATIENTS (280) WERE DISCHARGED AT DAY OF OPERATION, 11.9% (38 PATIENTS) HAD AN OVERNIGHT STAY AND 0.6% (2 PATIENTS) STAYED TWO NIGHTS. MEAN NUMBER OF DAYS OF ANALGESIC USE IS 2.1. AT THE 1 WEEK FOLLOW-UP VISIT, MINOR PAIN OR DISCOMFORT WAS REPORTED BY 45 PATIENTS (14%) AND AT 4 WEEKS 11 PATIENTS (3.4%) STILL HAD MINOR DISCOMFORT. AT 6 MONTHS, 1 PATIENT SUFFERED FROM PERSISTING LOCAL NUMBNESS. TWO RECURRENCES WERE NOTED, BOTH WERE RE-OPERATED. CONCLUSIONS : THIS OBSERVATIONAL STUDY CONFIRMS EARLIER FINDINGS WITH THIS SEMI-RESORBABLE SELF-GRIPPING MESH REGARDING OPERATION TIME, COMPLICATIONS AND RECURRENCE. THE OPEN LICHTENSTEIN HERNIA REPAIR WITH THE SEMI-RESORBABLE SELFGRIPPING PARIETEX PROGRIP MESH SEEMS TO OFFER A RELIABLE ALTERNATIVE FOR THE TREATMENT OF INGUINAL HERNIA WITH BENEFITS ON OPERATING TIME AS WELL AS ON POSTOPERATIVE PAIN. ACTA CHIRURGICA BELGICA. 113 (3) (PP 192-195), 2013. DATE OF PUBLICATION: MAY-JUNE 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168412 UNKNOWN PROGRIP MESH PRODUCT UNKNOWN PROGRIP MESH FTL SOFRADIM PRODUCTION UNKNOWN PROGRIP NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1