MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALYTE Y-MESH GRAFT

Model Number	Y500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Disability (2371)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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)." (b)(4).No sample received.
Event or Problem Description
It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability, impairment per additional information received the patient experienced periurethral pain, dyspareunia, apical vaginal pain, levator myalgia, frequency of urination, stress urinary incontinence, right and left lower abdominal pain, cystocele, laparoscopic adhesiolysis, sling removal, mesh removal, paravaginal repair, laparoscopic burch procedure, suprapubic pelvic pain, urine leakage, intrinsic sphincter dysfunction, stricture and atresia of vagina, urgency of urination, nocturia, feeling of incomplete bladder emptying, generalized intra-abdominal and pelvic swelling, mass and lump, right upper and lower quadrant pain, abdominal distention, urge incontinence, kidney infection, shortened vagina, severe pain at the apex, perineal abscess, retroperineal fibrosis on the left pelvic sidewall, left ureterolysis, adhesions, placement of ureteral stent, large amount of fibrosis and adhesive tissue at left ovary, pelvic scar tissue with removal, laparoscopic neovagina, left ovary removal, perineal body mass removal, hematoma, urinary tract infection, urinary retention, constipation, urethral kink, poor urinary stream, straining to void, low back pain, recurrent vaginal vault prolapse, anterior vaginal wall prolapse, sacral colpopexy with insertion of fortiva dermal graft, required multiple non surgical and surgical interventions, recurrent yeast infections, itching and discharge, vaginitis, pelvic pain, severe abdominal distention/bloating, anxiety and depression,bilateral obturator muscle myalgia, frequency, husband being stabbed with a wire suture during intercourse, extensive adhesions, incontinence without sensory awareness, placement of single incision altis sling, hematuria, overactive bladder, urethral inflammation with severe pain, rotational descent of the apex and bladder, bladder distention and spasms, spraying of urine, pelvic relaxation, bladder descensus, left ovary hemorrhagic cyst, perineal pain, unsuccessful bladder instillations and rescues, dysuria, pressure, feeling like a corn cob was in her rectum, recurrent urinary tract infections, cystitis, unable to hold bladder, myalgia, possible bacterial vaginitis, mixed urinary incontinence, sling revision, urethral lysis, retropubic mesh tape sling placement.

• Brand Name: ALYTE Y-MESH GRAFT
• Common Device Name: ALYTE Y-MESH GRAFT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9770161
• Report Number: 1018233-2020-01430
• Device Sequence Number: 19660152
• Product Code: OTO
• UDI-Device Identifier: 00801741016165
• UDI-Public: (01)00801741016165
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K101722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: Y500
• Device Catalogue Number: Y500
• Device Lot Number: HUXB0334
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 11 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 60