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	Abdominal Pain (1685); Anemia (1706); Asthma (1726); Chest Pain (1776); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Discomfort (2330); Injury (2348); Chest Tightness/Pressure (2463); Abdominal Distention (2601); Intermenstrual Bleeding (2665); Constipation (3274); Unspecified Blood or Lymphatic problem (4434); Cramp(s) /Muscle Spasm(s) (4521)
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).".
Event or Problem Description
The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Per additional information received, the patient has experienced chest tightness, abdominal/incisional pain (abdominal pain), blood loss, and tenderness.Per additional information received, the patient has experienced pain, impairment, limited enjoyment, limited activates, tenderness, spotting, blood loss, discomfort, nausea, abdominal distention, anemia, inability to void, abdominal pain and nonsurgical intervention.Per additional information received, the patient has experienced mesh exposure at vaginal apex and patient required additional surgical intervention.
Event or Problem Description
Per additional information received on 15nov2021, the patient has experienced cramping, foul smelling discharge, vaginal bleeding, urinary tract infections, pain while sexual intercourse, asthma, chronic constipation, and required additional surgical and non-surgical interventions.
Additional Manufacturer Narrative
2120="l".2193, 2225, 1726="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: 10986705
• Report Number: 1018233-2020-06373
• Device Sequence Number: 3299161
• 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): 12/03/2021

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: 10/31/2014
• Device Model Number: Y100
• Device Catalogue Number: Y100
• Device Lot Number: HUWJ0221
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 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: 12/10/2020
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GYNECARE TVT SLING SYSTEM; PROTACKS X2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 57 KG