BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - DULEX

    MDR report key: 3177260 · Received June 13, 2013

    Report

    Report Number
    1213643-2013-00259
    Event Type
    Injury
    Date Received
    June 13, 2013
    Report Date
    May 30, 2017
    Manufacturer
    BRIDGER BIOMED, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE, HOWEVER, CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO AND IF AVAILABLE, TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS REC'D TO DATE. IF ADD'L EVENT AND/OR EVALUATION INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDENDUM TO THE INITIAL REPORT. THIS SUPPLEMENTAL EMDR IS BEING SENT BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY. BASED ON REVIEW OF THE RECORDS THE DULEX MESH WAS NOT DISCUSSED IN THE SECOND PROCEDURE, SO THERE WAS NO IDENTIFICATION OF A PROBLEM ASSOCIATED WITH THE DULEX MESH AND IT REMAINED IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED WHICH FOUND NO ANOMALIES DURING THE MANUFACTURING PROCESS OF THE DEVICE. AS REPORTED IN THE MD EXAM NOTES, "PATIENT WAS DOING WELL FOR A YEAR AND A HALF, WAS STRAINING REALLY HARD LIFTING AN OBJECT AND THE PATIENT FELT A POP AND THE BLADDER FELL DOWN AGAIN." WITH THE CURRENT INFORMATION AVAILABLE NO DEFINITIVE CONCLUSION CAN BE MADE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: IT WAS ALLEGED THAT ON (B)(6) 2008, THE PT WAS IMPLANTED WITH A BARD DULEX MESH DURING AN UNSPECIFIED BLADDER PROCEDURE. ON (B)(6) 2009, THE PT WAS IMPLANTED WITH A NON DAVOL MESH. AS A RESULT OF HAVING THE PRODUCTS IMPLANTED IN HER, THE PT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, HAS UNDERGONE MEDICAL TREATMENT AND WILL LIKELY UNDERGO FURTHER MEDICAL TREATMENT AND PROCEDURES.

    Description of Event or Problem · 1

    AS WAS PREVIOUSLY REPORTED: THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENTS' ATTORNEY: IT WAS ALLEGED THAT ON (B)(6) 2008 THE PATIENT WAS IMPLANTED WITH A BARD DULEX MESH DURING A UNSPECIFIED BLADDER PROCEDURE. ON (B)(6) 2009 THE PATIENT WAS IMPLANTED WITH A NON DAVOL MESH. AS A RESULT OF HAVING THE PRODUCTS IMPLANTED IN HER, THE PATIENT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, HAS UNDERGONE MEDICAL TREATMENT AND WILL LIKELY UNDERGO FURTHER MEDICAL TREATMENT AND PROCEDURES. ADDENDUM TO THE PREVIOUS INFORMATION PROVIDED: THE FOLLOWING IS BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2008 - THE PATIENT WAS DIAGNOSED WITH A TOTAL PELVIC PROLAPSE, CYSTOCELE AND BLADDER IRRITATIVE SYMPTOMS SECONDARY TO PELVIC PROLAPSE. THE PATIENT UNDERWENT A TWO PART PROCEDURE WHICH INCLUDED A TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND SACROCOLPOPEXY WITH IMPLANT OF A BARD DULEX MESH. PER OPERATIVE REPORT DETAILS "BARD DUAL LAYER MESH (DULEX) WAS THEN UTILIZED AND WAS APPROPRIATELY TRIMMED ESPECIALLY THE POSTERIOR FORNIX DEFECT. A PROLENE SUTURE WAS UTILIZED OVER THE VAGINAL CUFF POSTERIORLY AND MULTIPLE SUTURES WERE PLACED AND THIS WAS THEN ANCHORED TO THE SUSPENSION MATERIAL (DULEX). THIS WAS THEN ALLOWED TO FOLLOW THE CURVE OF THE SACRUM AND THE OPPOSITE END WAS TIED TO THE SACRAL PROMONTORY USING A PROLENE SUTURE." ON (B)(6) 2009 - PATIENT HAD AN MD OFFICE EXAM WITH COMPLAINTS OF PELVIC DISCOMFORT/PAIN WITH A PELVIC BULGE, URINARY INCONTINENCE, URGENCY AND FREQUENCY. ON EXAM, THE PATIENT WAS NOTED TO HAVE A CYSTOCELE PRESENT. ON (B)(6) 2009 - THE PATIENT WAS DIAGNOSED WITH STRESS URINARY INCONTINENCE, PAIN, DIFFICULTY WITH URINATION AND CYSTOCELE. THE PATIENT UNDERWENT AN ANTERIOR COLPORRHAPHY, AUGMENTATION WITH A NON-BARD DAVOL BIOLOGIC, IMPLANT OF A NON-BARD DAVOL SLING AND VAGINAL MUCOSA BIOPSY. OPERATIVE DETAILS PROVIDED DID NOT MENTION ANY VISUALIZATION OR INVOLVEMENT OF THE DULEX MESH. ON (B)(6) 2011 - PATIENT HAD AN MD OFFICE EXAM WITH COMPLAINTS OF VAGINAL PROLAPSE, PELVIC DISCOMFORT AND BACK PAIN. PER THE MD EXAM NOTES, "PATIENT WAS DOING WELL FOR A YEAR AND A HALF, WAS STRAINING REALLY HARD LIFTING AN OBJECT AND THE PATIENT FELT A POP AND THE BLADDER FELL DOWN AGAIN." PATIENT WAS DIAGNOSED WITH A CYSTOCELE AND ADVISED TO USE A PESSARY FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269806 MESH - DULEX SURGICAL MESH FTL BRIDGER BIOMED, INC. NA BRRRF7157

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S