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

Model Number Y100

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient had recurrent prolapse of the uterus.The patient was placed on the waiting list for surgery and replacement of mesh.

Event Description

It was reported that the patient had recurrent prolapse of the uterus.Action taken: the patient was placed on w.I.For surgery and replacement of mesh.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found 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)." 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
• Type of Device: ALYTE Y-MESH GRAFT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9560478
• MDR Text Key: 174098570
• Report Number: 1018233-2020-00173
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 00801741016158
• UDI-Public: (01)00801741016158
• Combination Product (y/n): N
• PMA/PMN Number: K101722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Y100
• Device Catalogue Number: Y100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention