BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYS POSTERIOR

    MDR report key: 3501327 · Received November 21, 2013

    Report

    Report Number
    1018233-2013-09436
    Event Type
    Injury
    Date Received
    November 21, 2013
    Report Date
    October 25, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    OTP
    PMA / PMN Number
    K082571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE REACTIONS: "POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING HEMATOMA, SEROMA, MUCOSAL OR VISCERAL EROSION, INFECTION, INFLAMMATION, SENSITIZATION, DYSPAREUNIA, SCARIFICATION AND CONTRACTION, FISTULA FORMATION, EXTRUSION AND RECURRENCE OF VAGINAL WALL PROLAPSE. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, RECTUM, OR ANY VISCERA MAY OCCUR DURING NEEDLE PASSAGE." 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED MESH EROSION, DYSPAREUNIA, URINARY URGENCY, AND FREQUENCY AND SCIATIC PAIN, AND MESH REVISION/REMOVAL ON (B)(6) 2011.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED ABDOMINAL PAIN, CRAMPING, LOWER BACK PAIN, POSTOPERATIVE CONSTIPATION WHICH RESOLVED, A SLOWER STREAM, SENSE OF BLADDER FULLNESS, PRESSURE, HERPES, QUESTIONABLE SPOTTING, LEFT LEG PAIN, PALPABLE VAGINAL SLING, SENSATION OF THE SLING MOVING, GRAFT EROSION, RECTOCELE, PERINEAL LAXITY, NOCTURIA (X1), OVERACTIVE BLADDER, BLEEDING, VAGINAL DISCHARGE, PROPHYLACTIC USE OF ANTIBIOTICS, TEMPORARY INCREASE IN BLOOD UREA NITROGEN, LEFT ATROPHIC VAGINITIS, AND OVERACTIVE BLADDER. SHE UNDERWENT A REVISION OF THE POSTERIOR VAGINAL GRAFT AND RELEASE OF THE POSTERIOR VAGINAL GRAFT ON (B)(6) 2011 FOR WHICH PATHOLOGY CONFIRMED ACUTE AND CHRONIC GRANULOMATOUS GIANT CELL INFLAMMATION SECONDARY TO FOREIGN BODY. SHE ALSO UNDERWENT EXCISION OF A SUTURE ON (B)(6) 2011.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED JOINT PAIN AND REQUIRED ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604573 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYS POSTERIOR OTP C.R. BARD, INC. (COVINGTON) -1018233 NA CVRL0023

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention AVAULTA SOLO ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA SOLO ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM