MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH; SURGICAL MESH

Catalog Number 0112720

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Reaction (2414)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

As reported, post implant of a bard flat mesh, the patient had a allergic reaction.Based on the information provided, no conclusion can be made as to the degree to which the bard device, may be causing or contributing the patient's reported symptoms.As reported reactivity testing has been performed, and the results have been requested.At this time the results have not been provided.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march 2020.Note, the date of event provided is the best estimate based on the date of awareness of the reported event.Should the reactivity test results or any other additional information be provided, a supplemental mdr will be submitted.Remains implanted.

Event Description

As reported, the patient was recently implanted with a bard flat mesh, and had an allergic reaction.A mesh sample was obtained and used for reactivity testing.As reported, the nurse could not provide further information.

• Brand Name: BARD FLAT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 10952279
• MDR Text Key: 219862878
• Report Number: 1213643-2020-20065
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/01/2020

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: Health Professional
• Device Catalogue Number: 0112720
• Device Lot Number: HUEN1879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 12/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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