BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM

    MDR report key: 16126184 · Received January 9, 2023

    Report

    Report Number
    1000306051-2022-00230
    Event Type
    Injury
    Date Received
    January 9, 2023
    Date of Event
    March 22, 2016
    Report Date
    January 17, 2023
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. THE INTERNAL INVESTIGATION IS PENDING AND WILL BE REPORTED IN A FOLLOW UP REPORT ALONG WITH THE INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATION INTO STRATTICE LOT SP100157 INCLUDED A REVIEW OF THE REPORTED INFORMATION, REVIEW OF THE DEVICE HISTORY RECORDS, AND A REVIEW OF THE COMPLAINT HISTORY RECORDS. THE INVESTIGATION RESULTED IN NO REMARKABLE FINDINGS, INCLUDING NO OTHER COMPLAINTS REPORTED AGAINST THE LOT AND NO DEVIATIONS OR RELATED NON-CONFORMANCES REVEALED DURING PROCESSING. THE LOT WAS TERMINALLY STERILIZED WITHIN THE PROCESS PARAMETERS AND MET ALL QC RELEASE CRITERIA. AS OF 12 JAN 2023, OF THE (B)(4) DEVICES RELEASED TO FINISHED GOODS FOR LOT SP100157, (B)(4) HAVE BEEN DISTRIBUTED WITH (B)(4) REPORTED AS IMPLANTED. BASED ON OUR INTERNAL INVESTIGATION WITH NO REMARKABLE FINDINGS, AND WITHOUT RELEVANT PATIENT FACTORS, A RELATIONSHIP BETWEEN THE STRATTICE AND THIS EVENT COULD NOT BE DETERMINED. DUE TO THE LEGAL PROCESS, IF ADDITIONAL INFORMATION IS MADE AVAILABLE DURING LEGAL PROCEEDINGS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AS REPORTED IN THE INITIAL: THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. THE INTERNAL INVESTIGATION IS PENDING AND WILL BE REPORTED IN A FOLLOW UP REPORT ALONG WITH THE INVESTIGATION CONCLUSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 71 YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE MESH (LOT # SP1000005-149 REF # 1010002). AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2015, FOR A REVISION SURGERY AND ADDITIONAL STRATTICE MESH WAS IMPLANTED. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE MESH (LOT # SP100157 REF #1016002). ON (B)(6) 2016, THE PATIENT UNDERWENT AN INCISIONAL VENTRAL HERNIA REPAIR WITH STRATTICE. THE RECORDS INDICATE THAT TWO STRATTICE WERE IMPLANTED (CAT # 0808002 LOT # SP100300- 213; LOT # SP100176-204). IT WAS REPORTED THE PATIENT UNDERWENT MULTIPLE SUBSEQUENT RECURRENT VENTRAL AND INCISIONAL HERNIA REPAIR SURGERIES. NO OTHER INFORMATION WAS PROVIDED. THIS RECORD IS ASSOCIATED WITH DEVICE LOT # SP100157 REF #1016002). IMPLANTED (B)(6) 2015. ALTHOUGH A LOT NUMBER WAS REPORTED, THE SUBLOT WAS NOT INCLUDED; HOWEVER THE REF NUMBER OF 1016002 IS A VALID ITEM FOR LOT SP100157 AND THEREFORE AN INVESTIGATION WILL BE PERFORMED ON THE LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 71 YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE MESH (LOT # SP1000005-149 REF # (B)(4).). AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6).2015, FOR A REVISION SURGERY AND ADDITIONAL STRATTICE MESH WAS IMPLANTED. THE RECORDS INDICATE THIS IS A LIFECELL ¿ STRATTICE MESH (LOT # SP100157 REF #(B)(4).). ON (B)(6) 2016, THE PATIENT UNDERWENT AN INCISIONAL VENTRAL HERNIA REPAIR WITH STRATTICE. THE RECORDS INDICATE THAT TWO STRATTICE WERE IMPLANTED (CAT # 0808002 LOT # SP100300- 213; LOT # SP100176-204). IT WAS REPORTED THE PATIENT UNDERWENT MULTIPLE SUBSEQUENT RECURRENT VENTRAL AND INCISIONAL HERNIA REPAIR SURGERIES. NO OTHER INFORMATION WAS PROVIDED. THIS RECORD IS ASSOCIATED WITH DEVICE LOT # SP100157 REF #(B)(4)). IMPLANTED (B)(6) 2015. ALTHOUGH A LOT NUMBER WAS REPORTED, THE SUBLOT WAS NOT INCLUDED; HOWEVER THE REF NUMBER OF 1016002 IS A VALID ITEM FOR LOT SP100157 AND THEREFORE AN INVESTIGATION WILL BE PERFORMED ON THE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306499 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM MESH, SURGICAL FTM SP100157

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention NO INFORMATION REPORTED.