BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 2190444 · Received July 29, 2011

    Report

    Report Number
    1213643-2011-00360
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 15, 2004
    Report Date
    March 10, 2021
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONALLY, NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS IS AN ADDENDUM TO THE INITIAL MDR TO DOCUMENT ADDITIONAL INFORMATION PROVIDED BY THE PATIENT. THE PATIENT HAS NOT PROVIDED A LOT NUMBER, THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. BASED ON THE LIMITED INFORMATION PROVIDE TO DATE, NO CONCLUSIONS CAN BE MADE. IF ADDITIONAL INFORMATION IS OBTAINED, 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. NO SAMPLE.

    Description of Event or Problem · 1

    IN 2003/2004 - PATIENT UNDERWENT MESH IMPLANT. SIX-NINE MONTHS LATER THE PATIENT UNDERWENT EXPLORATORY SURGERY FOR SEVERE PAIN AND LEFT TESTICLE RETRACTION INTO THE ABDOMEN. THE MEDICAL DOCTOR DISCOVERED A FOLD IN THE PATCH. A PORTION OF THE MESH WAS CUT. ACCORDING TO THE PATIENT, THE SURGEON THOUGHT THERE WAS NERVE ENTRAPMENT. DURING ANOTHER OPERATIVE PROCEDURE, THE PATIENT'S LEFT TESTICLE WAS SUBSEQUENTLY REMOVED. PATIENT REPORTS HE CONTINUES TO HAVE MEDICAL PROBLEMS AND EXTREME STRESS RELATED TO THE CONDITION OF THE MESH.

    Description of Event or Problem · 1

    2003/2004--PATIENT UNDERWENT MESH IMPLANT. SIX (6-9) MONTHS LATER THE PATIENT UNDERWENT EXPLORATORY SURGERY FOR SEVERE PAIN AND LEFT TESTICLE RETRACTION INTO THE ABDOMEN. THE MD DISCOVERED A FOLD IN THE PATCH. A PORTION OF THE MESH WAS CUT. ACCORDING TO THE PATIENT, THE SURGEON THOUGHT THERE WAS NERVE ENTRAPMENT. DURING ANOTHER OPERATIVE PROCEDURE, THE PATIENTS' LEFT TESTICLE WAS SUBSEQUENTLY REMOVED. PATIENT REPORTS HE CONTINUES TO HAVE MEDICAL PROBLEMS AND EXTREME STRESS RELATED TO THE CONDITION OF THE MESH. THIS IS AN ADDENDUM TO THE INITIAL MDR AND IS BASED ON ADDITIONAL INFORMATION PROVIDED BY THE PATIENT: IN (B)(6) 2003 - THE PATIENT WAS IMPLANTED WITH A BARD KUGEL HERNIA PATCH, FOR THE REPAIR OF AN INGUINAL HERNIA. NI/NI/2004 - THE PATIENT UNDERWENT EXPLORATORY SURGERY AND DURING THIS PROCEDURE A PORTION OF THE MESH WAS CUT OFF BY THE SURGEON AS IT WAS NOTED TO BE FOLDED, CAUSING NERVE ENTRAPMENT. NI/NI/2008 - THE PATIENT UNDERWENT PROCEDURE TO REMOVE THE "LEFT TESTICLE AND CORD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R