BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3132505 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-05981
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT ON (B)(6) 2013, THE MESH WAS REMOVED AND REPLACED. SINCE THEN, THE PAIN, DISCOMFORT AND INFECTIONS HAVE GONE AWAY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LOWER INGINUAL HERNIA REPAIR PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. THE PATIENT BEGAN EXPERIENCING DISCOMFORT SHORTLY AFTER THE PROCEDURE AND IS NOW EXPERIENCING REPEATED INFECTIONS. THE PATIENT WENT TO A PAIN MANAGEMENT CLINIC, BUT AFTER STOPPING, CONTINUED TO EXPERIENCE INTERMITTENT DISCOMFORT FOR SEVERAL YEARS. IT WAS A NEUROPATHIC-TYPE PAIN IN THE LEFT GROIN WITH INTERMITTENT SWELLING, PARASTHESIA AND PAIN. HE RESPONDED TO INJECTIONS AND NEURONTIN 300MG 3X DAILY. ABOUT TWO YEARS AGO, THE DISCOMFORT INCREASED AND THE PATIENT STARTED HAVING REDNESS AND SWELLING IN THE SURGICAL AREA. THE PATIENT HAD REPEATEDLY BEEN PLACED ON ANTIBIOTICS FOR INFECTIONS. THE PATIENT HAS BEEN TOLD THAT THE MESH NEEDS TO BE REMOVED. THE PRIMARY CARE PHYSICIAN OPINES THAT IT IS LIKELY THAT THE MESH OR SCAR TISSUE HAS CAUSED ENTRAPMENT OF A NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237463 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UBB053

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention