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	Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Neuropathy (1983); Pain (1994); Pelvic Inflammatory Disease (2000); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Vertigo (2134); Dizziness (2194); Urinary Frequency / Polyuria (2275); Anxiety (2328); Injury (2348); Depression (2361); Disability (2371); Numbness (2415); Prolapse (2475); Abdominal Distention (2601); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed.No sample was returned for evaluation.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue.The labeling of use was found to be adequate and state the following."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).Sample not 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 and impairment.Per additional information received, the patient has experienced epidural abscess, urinary tract infection with extended spectrum beta-lactamase (esbl), vertebral osteomyelitis multiple levels, diskitis, pelvic inflammatory disease, extended-spectrum beta-lactamase escherichia coli infection, referred pain, lower back pain, anxiety, depression, bladder dysfunction and distention, left lower extremity pain, new pains in the right knee and ankle, right ischial area, radiating to knee, constant pain in the pelvic area and radiated to the right leg, phlegmon osteomyelitis, infection of laparoscopic sacral colpopexy mesh, inflammation on the anterior surface and possible involvement of graft, overflow incontinence, abdominal pain, subcutaneous abscess.Additionally, the patient required surgical and non-surgical interventions.
Additional Manufacturer Narrative
Correction: g1.1735,1928="l" 1690, 2120,2000,2328,2361,2601,1685,2564,2519,1908,2067,2119,2475,2194,2193,2134,2415.= "nl".
Event or Problem Description
Per additional information received via medical records on 26aug2022, the patient has experienced chronic pain, abscess, lower back pain, urinary tract infection, cystocele, diabetes, dyspareunia, hypertension, sepsis, rectocele, urinary incontinence, urinary retention, uterine prolapse, lumbosacral radiculopathy, dizziness, muscle cramp, back pain, sensory neuropathy, chronic bilateral low back pain with right-sided sciatica, vertigo, hyperreflexia, gait difficulty, otalgia, left leg numbness, infection of laparoscopic sacral colpopexy mesh, endometriosis of uterus, prolapse of genital organs, atrophic vaginitis, increased frequency of urination and endometrium thickened and required additional surgical and non-surgical interventions.

• 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: juan velez ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10254149
• Report Number: 1018233-2020-04436
• Device Sequence Number: 13601777
• Product Code: OTO
• UDI-Device Identifier: 00801741016165
• UDI-Public: (01)00801741016165
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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: 05/28/2018
• Device Model Number: Y500
• Device Catalogue Number: Y500
• Device Lot Number: HUAT0975
• 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: 06/24/2020
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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: BARD IMPLANT STAPLES; BARD IMPLANT STAPLES; BOSTON SCIENTIFIC OBTRYX II HALO; BOSTON SCIENTIFIC OBTRYX II HALO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White