BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 6702997 · Received July 11, 2017

    Report

    Report Number
    1213643-2017-00400
    Event Type
    Injury
    Date Received
    July 11, 2017
    Report Date
    July 14, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016615
    PMA / PMN Number
    K922916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THERE WERE NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS OF THE DEVICE. AT THIS TIME THE MAUDE EVENT REPORT DOES NOT INDICATE THAT THE PATIENT UNDERWENT ANY TYPE OF MEDICAL/SURGICAL INTERVENTION. THE MAUDE EVENT REPORT INDICATES THE PATIENT HAD "A HERNIA REPAIR WITH A BARD MESH AND A BARD PERFIX PLUG." THE CONTENTS OF THE PERFIX PLUG INCLUDE AN ONLAY MESH AS WELL AS THE PLUG ITSELF. BASED ON NOT HAVING ANY ADDITIONAL PRODUCT IDENTIFIERS, IT APPEARS THAT THE "BARD MESH" THAT WAS USED IN THE PROCEDURE IS THE ONLAY MESH THAT IS INCLUDED WITH THE PERFIX PLUG. THE MAUDE EVENT REPORT DID NOT INCLUDE CONTACT INFORMATION FOR THE COMPLAINANT; AS SUCH NO ATTEMPTS CAN BE MADE TO REQUEST ADDITIONAL INFORMATION. BASED ON THE INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD 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 BARD. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS IS AN ADDENDUM TO THE INITIAL MDR TO CORRECT THE MAUDE EVENT REPORT NUMBER THAT WAS REFERENCED. THE CORRECT NUMBER IS MAUDE EVENT REPORT (MW5070241).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5069089). "I HAD A HERNIA REPAIRED WITH A BARD MESH AND A BARD PERFIX PLUG (LOT NUMBER HUVJ0351). ALCOHOL USE TO ALLEVIATE THE PAIN."

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5069089). "I HAD A HERNIA REPAIRED WITH A BARD MESH AND A BARD PERFIX PLUG (LOT NUMBER HUVJ0351). ALCOHOL USE TO ALLEVIATE THE PAIN." THIS IS AN ADDENDUM TO THE INITIAL MDR TO CORRECT THE MAUDE EVENT REPORT NUMBER LISTED ABOVE THE CORRECT NUMBER IS MAUDE EVENT REPORT (MW5070241).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483168 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. 0112770 HUVJ0351 00801741016615

    Patients

    Seq Age Sex Outcome Treatment
    1 Other