BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 17181160 · Received June 22, 2023

    Report

    Report Number
    1213643-2023-00241
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    June 14, 2021
    Report Date
    June 27, 2023
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES ADVERSE PATIENT OUTCOME ASSOCIATED WITH THE HERNIA MESH USED TO TREAT THE PATIENT INCLUDING NERVE ENTRAPMENT, NERVE DAMAGE, INFLAMMATION, CONTINUOUS MEDICAL TREATMENT AND REMOVAL OF THE MESH. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE IDENTIFIES INFLAMMATION AS A POSSIBLE COMPLICATION. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : NOT RETURNED.

    Additional Manufacturer Narrative · 0

    NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES ADVERSE PATIENT OUTCOME ASSOCIATED WITH THE HERNIA MESH USED TO TREAT THE PATIENT INCLUDING NERVE ENTRAPMENT, NERVE DAMAGE, INFLAMMATION, CONTINUOUS MEDICAL TREATMENT AND REMOVAL OF THE MESH. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE IDENTIFIES INFLAMMATION AS A POSSIBLE COMPLICATION. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. H11: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED (MDR NUMBER 1213643-2023-00241). THIS SUPPLEMENTAL EMDR IS BEING SUBMITTED TO CORRECT THE EVENT DESCRIPTION, ANNEX E, D CODES AND MANUFACTURER NARRATIVE. NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES ADVERSE PATIENT OUTCOME ASSOCIATED WITH THE HERNIA MESH USED TO TREAT THE PATIENT INCLUDING NERVE DAMAGE, PAIN, DISABILITY AND REMOVAL OF THE MESH. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF IMPLANT IS CONSIDERED TO BE A BEST ESTIMATE BASED ON THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : NOT RETURNED.

    Description of Event or Problem · 0

    PER LEGAL CLAIM CASE NO: (B)(4). ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY AND IMPLANTED WITH PERFIX PLUG ON (B)(6) 2020. ON OR AROUND (B)(6) 2021 AND (B)(6) 2022, THE PATIENT UNDERWENT ADDITIONAL SURGERIES DUE TO DEFECTIVE QUALITIES OF THE PERFIX PLUG. IT WAS REPORTED THAT BETWEEN 2020 AND THE PRESENT, PATIENT SUFFERED FROM NERVE ENTRAPMENT, NERVE DAMAGE, INFLAMMATION, CONTINUOUS MEDICAL TREATMENT, TESTING AND A SUBSEQUENT SURGERY REQUIRING THE REMOVAL OF THE PERFIX PLUG. IT WAS ALSO REPORTED THAT PATIENT CONTINUES TO SUFFER FROM THE NERVE PAIN AND REQUIRES ONGOING MEDICAL TREATMENT. PATIENT SUFFERED AND WILL CONTINUES TO SUFFER SEVERE AND PERMANENT PERSONAL INJURIES INCLUDING BUT NOT LIMITED TO PAIN, SUFFERING AND DISABILITY.

    Description of Event or Problem · 0

    ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY AND WAS IMPLANTED WITH PERFIX PLUG ON (B)(6) 2020. ON OR AROUND (B)(6) 2021 AND (B)(6) 2022, PATIENT UNDERWENT ADDITIONAL SURGERIES DUE TO DEFECTIVE QUALITIES OF THE PERFIX PLUG. IT IS ALLEGED THAT BETWEEN 2020 AND THE PRESENT, PATIENT SUFFERED FROM NERVE ENTRAPMENT, NERVE DAMAGE, CONTINUOUS MEDICAL TREATMENT, TESTING AND A SUBSEQUENT SURGERY REQUIRING THE REMOVAL OF THE PERFIX PLUG. IT IS ALSO ALLEGED THAT PATIENT CONTINUES TO SUFFER FROM THE NERVE PAIN AND REQUIRES ONGOING MEDICAL TREATMENT. IT IS ALLEGED THAT THE PATIENT SUFFERED AND WILL CONTINUE TO SUFFER SEVERE AND PERMANENT PERSONAL INJURIES INCLUDING BUT NOT LIMITED TO PAIN, SUFFERING AND DISABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69798 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Disability| R