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

Model Number Y100

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

Patient Problems Injury (2348); Blood Loss (2597); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

August 2018 quarterly asr report.(b)(4).The total number of events for product classification code oto is 35.Qty 19- alyte y-mesh graft, sterile; qty 16- alyte y-mesh graft, sterile (5-pack).The information provided by bard 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 bard.(b)(4).Sample not received.

Event Description

August 2018 quarterly asr report.

Event Description

N/a.

Manufacturer Narrative

Exemption (b)(4).Original reporting time frame may 1, 2018 through july 31, 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: 7782662
• MDR Text Key: 117126998
• Report Number: 1018233-2018-03554
• 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: other
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

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
• Device Operator: No Information
• Device Expiration Date: 10/31/2014
• Device Model Number: Y100
• Device Catalogue Number: Y100
• Device Lot Number: HUWH1801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention