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

Catalog Number 0112680

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Pain (1994); Rash (2033); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient.A sample mesh has been provided to the patient's allergist for reactivity testing.As reported, at this time the reactivity testing has not been completed.A review of the manufacturing records was performed and found that the lot was manufactured to specification.If/when the results of the reactivity testing have been provided, a supplemental emdr will be submitted to document the results.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.Remains implanted.

Event Description

The following was reported to davol by the patient's allergist: as reported on (b)(6) 2015 the patient underwent left inguinal hernia repair and was implanted with a bard/davol flat mesh.Soon after the implant procedure, the patient experienced pain and a rash at the incision site.As reported the rash is chronic and covered most of his body and consists of blisters and "patchy lesions." the patient has been taking steroids consistently to control the rash; however, this has not provided complete resolution of the rash.A sample mesh was requested for reactivity testing.

Manufacturer Narrative

This is an addendum to the initial emdr to document the results of the reactivity testing.Reactivity testing has been performed and it has been reported that the patient showed a negative response to the mesh when placed on his skin.The md indicates the patient's symptoms are most consistent with contact dermatitis with the specific allergen that has not yet been identified.As such it is concluded that the reported patient condition was not due to the davol mesh implant.

• Brand Name: BARD FLAT 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: 7290211
• MDR Text Key: 100755766
• Report Number: 1213643-2018-00357
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Catalogue Number: 0112680
• Device Lot Number: HUZC1565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2015
• 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
• Patient Age: 65 YR