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

Model Number	Y100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Frequency / Polyuria (2275); Injury (2348); Disability (2371); Prolapse (2475); Urinary Incontinence (4572)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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)." 1994 = "l" 2348, 2371, 2993 = "nl" the information provided by bd 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 bd.
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 pain, injury, disability, impairment, and required non-surgical interventions.
Event or Problem Description
Per additional information received on 15nov2021, the patient has experienced pain from genitourinary prosthetic graft, chronic pelvic pain, rectocele, enterocele, urinary retention, pelvic organ prolapse, mixed urinary incontinence, urinary urgency, urinary frequency, nocturia, right hip pain, exquisite pain with gentle palpitation of vaginal cuff and right adnexa, sacral or buttock pain and required additional surgical and non-surgical interventions.
Additional Manufacturer Narrative
2475="l".1871, 2275, 2467="nl".H11:section a through f - the information provided by bd 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 bd.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 11028326
• Report Number: 1018233-2020-06381
• Device Sequence Number: 14339813
• Product Code: OTO
• UDI-Device Identifier: 00801741016158
• UDI-Public: (01)00801741016158
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 12/07/2021

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: 11/30/2014
• Device Model Number: Y100
• Device Catalogue Number: Y100
• Device Lot Number: HUWJ0222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 88 KG