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 Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Nov 2018 quarterly asr report.Exemption (b)(4).The total number of events for product classification code oto is 13.Qty 6- alyte y-mesh graft, sterile.Qty 7- alyte y-mesh graft, sterile (5-pack).[(b)(4) nov 2018 quarterly oto.Xlsx].No sample received.

Event Description

November 2018 quarterly asr report.

Manufacturer Narrative

Exemption (b)(4).Original reporting time frame: (b)(6)2018 through (b)(6)2018.

• 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: 8051727
• MDR Text Key: 126564309
• Report Number: 1018233-2018-05254
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 00801741016165
• UDI-Public: (01)00801741016165
• Combination Product (y/n): N
• PMA/PMN Number: K101722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2016
• Device Model Number: Y500
• Device Catalogue Number: Y500
• Device Lot Number: HUYE1214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention