BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETENE PROGRIP RT PPL/PLA 12X8CM

    MDR report key: 5246933 · Received November 24, 2015

    Report

    Report Number
    9615742-2015-00112
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    March 15, 2010
    Report Date
    October 6, 2015
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K101197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SEE REFERENCE NUMBERS (B)(4) FOR OTHER TWO CASES INVOLVING RECURRENT HERNIA WITHOUT TREATMENT INFORMATION. LITERATURE REFERENCE - HTTP://RD.SPRINGER.COM/ARTICLE/10.1007/S10029-014-1316-7/FULLTEXT.HTML

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A RANDOMIZED CLINICAL TRIAL WAS CARRIED OUT. THE STUDY WAS DONE BETWEEN SEPTEMBER 2008 AND OCTOBER 2010, WITH A TOTAL NUMBER OF 94 PATIENTS INCLUDED. 89 PATIENTS WERE INCLUDED IN THE STUDY RESULTS COMPRISED OF INDIVIDUALS PRESENTING WITH PRIMARY BILATERAL INGUINAL HERNIA, OLDER THAN 17 YEARS OF AGE AND WITH NON-COMPLICATED HERNIA. THERE WERE 87 MALES AND 2 FEMALES. THE MEAN AGE WAS 55.7 YEARS +/- 12.27 YEARS. THE ANESTHETIC PROCEDURE USED IN ALL CASES WAS REGIONAL ANESTHESIA. THE MEDIUM FOLLOW-UP WAS 18.2 +/- 7.2 MONTHS. IN THIS CASE, A PATIENT SUFFERED A RECURRENCE. NO TREATMENT INFORMATION WAS PROVIDED. THE DOCTOR INDICATED, DURING FOLLOW-UP REGARDING THE EVENT, THAT THE MESH WAS ONE OF MANY FACTORS THAT AFFECTED THE ADVERSE EVENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778373 PARIETENE PROGRIP RT PPL/PLA 12X8CM MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION PP1208DR SJJ00630

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention