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

Catalog Number 0117016

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Edema (1820); Urticaria (2278); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Based on the information provided at this time no conclusion can be made as to the degree to which the bard soft mesh may be causing or contributing to the patient's reported condition.The patient's doctor is being provided with a mesh sample for reactivity testing.At this time the testing has not been completed.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of 199 units.Lot was released for distribution in july, 2018.Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.

Event Description

It was reported that on (b)(6) 2018 the patient was implanted with a bard soft mesh.As reported the patient has experienced frequent hives and angioedema of unknown origin.The patient is concerned that she has developed an allergic reaction to the mesh that was used during the surgery.The allergist reports this is unlikely, but would like to rule out the possibility and has requested a sample mesh for reactivity testing.

• Brand Name: BARD SOFT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 8412142
• MDR Text Key: 138524209
• Report Number: 1213643-2019-01605
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Catalogue Number: 0117016
• Device Lot Number: HUCT0947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• 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