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

Model Number Y500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Injury (2348)

Event Type  Injury  

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)(6).

Event 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 pain, low red blood cells/hematocrit/hemoglobin and nonsurgical intervention.Per additional information received, the patient has experienced scarring (scar tissue), erosion, pain, depression, pain with intercourse, anxiety, bloating, vaginal/groin pain, internal pain, foreign body in patient, abdominal pain, inability to have intercourse, ambulation difficulties, adhesions, unspecified bowel problems, dyspareunia, incontinence, low red blood cells/hematocrit/hemoglobin, ureteral stricture (obstruction), enterocele (prolapse), blood loss, inflammation, fibrosis, foreign body reaction, nonsurgical and additional surgical interventions.Per additional information received, the patient required additional surgical and non-surgical interventions.

• Brand Name: ALYTE Y-MESH GRAFT
• Type of Device: 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: 10135556
• MDR Text Key: 194600446
• Report Number: 1018233-2020-03711
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 00801741016165
• UDI-Public: (01)00801741016165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: Y500
• Device Catalogue Number: Y500
• Device Lot Number: HUXG0618
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 75