MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Alyte¿ Y-Mesh Graft; Pelvic Mesh

Catalog Number	Y100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Anemia (1706); Erosion (1750); Fever (1858); Micturition Urgency (1871); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275); Anxiety (2328); Distress (2329); Prolapse (2475); Dysuria (2684); Urinary Incontinence (4572); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
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 exposure of vaginal mesh through vaginal wall, erosion of implanted vaginal mesh and prosthetic materials, overactive bladder, mixed stress and urge urinary incontinence, urinary tract infection, detrusor dysfunction.Per medical records were received on 23jun2026, the patient has experienced severe bowel adhesions to the vaginal cuff, severe bowel adhesions to the pelvic sidewall, severe bowel adhesions to the pelvis posterior cul-de-sac, urinary incontinence, narrowed vaginal introitus, vaginal mesh erosion at the apex, bleeding, vaginal prolapse, hemorrhage, edema, anemia, overactive bladder, urinary retention, e coli urinary tract infection, stress, lower back pain, dysuria, frequency, fever, vaginal wound, urethral wound, overactive genitourinary, pain, incomplete emptying of bladder, detrusor dysfunction, urgency, anxiety, mesh exposure and required additional surgical and non-surgical treatments.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Udi format updated with available product information per gudid.H11: sections a through f - the information provided by bd represents all 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: Pelvic Mesh
• 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: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 25856899
• Report Number: 1018233-2026-04715
• Device Sequence Number: 5456489
• Product Code: OTO
• UDI-Device Identifier: 00801741016158
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: US
• PMA/510(K) Number: K101722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: 11/28/2017
• Device Catalogue Number: Y100
• Device Lot Number: HUZK1190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2015
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 129 LB
• Patient Race: White