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

Catalog Number	0175101
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Injury (2348)
Date of Event	04/11/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol mesh ¿ dulex (device #1).An additional emdr was submitted to represent bard/davol mesh ¿ ventralex (device #2).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol dulex on (b)(6) 2013 and ventralex hernia patch on (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Updated fields: a2, a4, b3, b4, b5, b6, b7, d4, d.6b (date of explant), g3, g6, h2, h6, h10.This supplemental emdr represents the bard/davol mesh - dulex (device #1).An additional supplemental emdr was submitted to represent the bard/davol mesh - ventralex (device #2).Note: section a through f - the information provided by bd 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 bd.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol dulex on (b)(6) 2013 and ventralex hernia patch on (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with large ventral hernia thereby underwent open repair with the implant of dulex mesh (device #1).Per operative notes, "two hernias notes, one slightly superior and another slightly superior to right.A bard dulex mesh (device #1) was placed and sutured." (b)(6) 2014 - patient was diagnosed with recurrent ventral hernia and adhesions thereby underwent open repair with the removal of mesh (device #1) and implant of ventralex mesh (device #2).Per operative notes, "the old mesh (device #1) has migrated inferiorly, this was removed.A ventralex mesh (device #2) was placed and sutured.".

• Brand Name: MESH ¿ DULEX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BRIDGER BIOMED, INC. -3031159; 2430 north 7th avenue; bozeman MT 59715
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 10814490
• Report Number: 1213643-2020-10132
• Device Sequence Number: 4123470
• Product Code: FTL
• UDI-Device Identifier: 00801741011931
• UDI-Public: (01)00801741011931(17)180628(10)BRXF0008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K003917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2018
• Device Catalogue Number: 0175101
• Device Lot Number: BRXF0008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 71 KG