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	Bruise/Contusion (1754); Pain (1994); Injury (2348)
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).
Event or Problem Description
The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced pain, bruising around umbilicus, failed voiding trial, post void residual (urinary retention), sinus bradycardia, unable to void, foley catheter re-insertion, burning pain (burning sensation), urinary incontinence, back pain, cystocele (prolapse), pessary use, right leg tingling sensation, pelvic pain, dysuria, feels she can¿t empty bladder all the way, hip pain, blood in urine, inflammation, problems walking (ambulation difficulties), headaches, incisional pain, purulent drainage, candidiasis (fungal infection), cellulitis (bacterial infection) and nonsurgical interventions, pain, infection, urinary problems, urinary incontinence, recurrence, anxiety disorder and mania, bipolar, mood swings, chronic pain syndrome, diabetes mellitus type 2, hyperglycemia, chronic obstructive disease/restrictive lung disease (copd), joint pain/right hip pain/polyarthralgias (joint pain), sciatica, hip/back pain, hyperlipidemia/hypercholesterolemia, insomnia, elevated blood pressure/hypertension, swollen glands/sore throat, stomach spasms, right leg tingling sensation (tingling), ¿feels like she can¿t empty bladder all the way¿ (urinary retention), weight gain/weight loss (weight flux), suprapubic pain/pelvic pain (abdominal pain), dysuria, cystocele (prolapse), hematuria, acute bronchitis, headaches, thyroid goiter (thyroid problems), surgical wound with scant purulent drainage, candidiasis (fungal infection), bacteria in urine (bacterial infection) (urinary tract infection), required additional non-surgical interventions, candidiasis, chronic constipation, feelings of incomplete bladder emptying, increased pain in hip and back area, suprapubic pain, pessary trial, pelvic pain, dysuria, urinary incontinence, and anemia requiring a transfusion, urinary tract infections, kidney problems, sharp stomach pain, internal bleeding, lack of bowel control, diarrhea, blood in stool requiring blood transfusion, bowel obstruction, dyspareunia and hernias.

• 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: 9866238
• Report Number: 1018233-2020-02006
• Device Sequence Number: 19629067
• Product Code: OTO
• UDI-Device Identifier: 00801741016165
• UDI-Public: (01)00801741016165
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K101722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2020

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: 02/28/2015
• Device Model Number: Y500
• Device Catalogue Number: Y500
• Device Lot Number: HUXA1441
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/23/2020
• 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: 51 YR
• Patient Weight: 79