BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALYTE Y-MESH GRAFT

    MDR report key: 3216964 · Received July 8, 2013

    Report

    Report Number
    1018233-2013-02761
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    July 28, 2017
    Manufacturer
    BARD SHANNON LIMITED -3005636544
    Product Code
    OTO
    PMA / PMN Number
    K101722
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNK; 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. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ALYTE Y-MESH GRAFT MAY INCLUDE, BUT ARE NOT LIMITED TO THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS INCLUDING: POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND OTHER VOIDING AND DEFECATORY DYSFUNCTIONS. THESE CONDITIONS MAY BE ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, URETHRA, RECTUM, OR ANY VISCERA, WHICH MAY OCCUR DURING THE IMPLANTATION PROCEDURE. IRRITATION AT THE OPERATIVE WOUND SITE WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO WOUND DEHISCENCE, INFLAMMATION AND/OR INFECTION. EXTRUSION THROUGH VAGINAL EPITHELIUM OR EROSION INTO SURROUNDING VISCERA AND/OR MUCOSA. INFLAMMATION, SENSITIZATION, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF VAGINAL WALL PROLAPSE. URINARY INCONTINENCE (STRESS AND URGE). (B)(4).

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ALYTE Y-MESH GRAFT MAY INCLUDE, BUT ARE NOT LIMITED TO THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS INCLUDING: POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND OTHER VOIDING AND DEFECATORY DYSFUNCTIONS. THESE CONDITIONS MAY BE ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, URETHRA, RECTUM, OR ANY VISCERA, WHICH MAY OCCUR DURING THE IMPLANTATION PROCEDURE. IRRITATION AT THE OPERATIVE WOUND SITE WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO WOUND DEHISCENCE, INFLAMMATION AND/OR INFECTION. EXTRUSION THROUGH VAGINAL EPITHELIUM OR EROSION INTO SURROUNDING VISCERA AND/OR MUCOSA. INFLAMMATION, SENSITIZATION, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF VAGINAL WALL PROLAPSE. URINARY INCONTINENCE (STRESS AND URGE). 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

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED FOREIGN BODY IN VULVA AND VAGINA, PINKISH VAGINAL DISCHARGE, FIRM GRANULATION TISSUE (GRANULOMA), SPOTTING AFTER INTERCOURSE (VAGINAL SPOTTING), DYSPAREUNIA, INSOMNIA, URINARY TRACT INFECTION, LYMPHOCYTIC COLITIS (DIARRHEA), HOT FLASHES, DRY SKIN, SENSITIVE TO HEAT AND COLD (TEMP BODY ALTERATION), JOINT PAIN, ¿ATROPHIC VAGINA WITH SINGLE STRAND CLEAR MESH VISIBLE AT APEX,¿ ATROPHIC VAGINITIS (INFLAMMATION), EROSION OF IMPLANTED VAGINAL MESH AND OTHER PROSTHETIC MATERIALS TO SURROUNDING ORGAN AND TISSUE, EXTRUDED MESH AS THE VAGINAL CUFF, LEVATOR MUSCLE TENDERNESS, PELVIC PROLAPSE, RECURRENT CYSTOCELE, EXTRUSION OF VAGINAL MESH, NOCTURIA, ¿LEAKS IF CAN¿T GET TO RESTROOM,¿ URGENCY OF URINATION, URINARY FREQUENCY, URGE INCONTINENCE, STRESS URINARY INCONTINENCE AND DISCOMFORT. MAGNETIC RESONANCE IMAGING (MRI) OF THE PELVIS SHOWED EXTENSIVE SUSCEPTIBILITY ARTIFACT AND POSTOPERATIVE CHANGE PRESENT WITHIN THE VAGINAL CUFF, RIGHT OVARY SHOWED MULTIPLE FOLLICLES AND A HEMORRHAGIC LESION, CYST MEASURING 8MM, LEFT OVARY SHOWED PRESENCE OF A DOMINANT FOLLICLE (CYST), FOREIGN BODY GIANT CELL REACTION FROM SUTURE, POSTOPERATIVE PAIN, AND REQUIRED ADDITIONAL SURGICAL AND NONSURGICAL INTERVENTIONS.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED IN THE PT'S MEDICAL RECORDS THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED LEFT HIP PAIN (FELT TO BE SECONDARY TO POSITIONING DURING SURGERY); LOWER QUADRANT PAIN POST VAGINAL SURGERY; AN INHOMOGENEOUS 4-5 CM AREA INTERPOSED BETWEEN THE RECTUM LEVEL OF THE VAGINA AND PUBIS WORRISOME FOR AN ABSCESS; A SMALL AMOUNT OF SUBCUTANEOUS AIR IN THE SUBCUTANEOUS FAT ANTERIOR TO THE PUBIS AND SLIGHTLY SUPERIOR TO THE PUBIS; PELVIC PAIN (SEVERE, POSTOPERATIVE, LOWER GROIN, BILATERAL, NEAR PUBIC BONE); VAGINAL BLEEDING (WORSENING, POSTOPERATIVE); "DOESN'T HAVE THE NORMAL URGE TO URINATE", CLEAR DISCHARGE (VAGINAL); URINARY INCONTINENCE; GROIN PAIN (BILATERAL, CHRONIC); ABDOMINAL PAIN RIGHT LOWER QUADRANT; INTRINSIC SPHINCTER DEFICIENCY; VAGINAL VAULT PROLAPSE; CHRONIC SUPRAPUBIC PAIN; DECREASED COAPTATION IN THE URETHRA; OVARIAN CYSTS; URINALYSIS WITH POSITIVE RESULTS FOR PROTEIN AND MODERATE AMOUNTS OF AMORPHOUS CRYSTALS; AND ABDOMINAL BLOATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311587 ALYTE Y-MESH GRAFT OTO BARD SHANNON LIMITED -3005636544 NA HUVL1213

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention