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

Catalog Number	0115191
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The attorney alleges unspecified injuries; however no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible.Information is limited at this time.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 an unspecified bard/davol dulex on (b)(6) 2008.As reported, the patient is making a claim for an adverse patient outcome against the dulex.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." attorney alleges unspecified injuries.
Additional Manufacturer Narrative
At this time no conclusions can be made.The attorney alleges unspecified injuries; however, no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible.Information is limited at this time.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the manufacturer.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, b2, b3, b4, b5, b7, d1, d3, d4, d6b, g1, g3, g6, h2, h6, h10, h11.Corrected field: d3 (manufacturer).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.H3 other text : not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol dulex on (b)(6) 2008.As reported, the patient is making a claim for an adverse patient outcome against the dulex.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." attorney alleges unspecified injuries.Addendum per additional information provided: addendum per medical records and plaintiff profile form: (b)(6) 2008 - patient was diagnosed with ventral incisional hernia thereby underwent laparoscopic repair with the implant of dulex mesh.Per op notes, ¿a dulex mesh was placed into the peritoneal cavity and tacked up to the abdominal wall using tacks.¿ (b)(6) 2016 - patient was diagnosed with small bowel obstruction & intra-abdominal adhesions thereby underwent exploratory laparotomy and extensive lysis of adhesions, release of small bowel obstruction.Per op notes, ¿there was a dense amount of scar tissue in the subcutaneous tissue and was dissected down.Dissected adhesions between the small bowel and the underside of the anterior rectus fascia.¿ (b)(6) 2017 - patient was diagnosed with incisional hernia thereby underwent open repair with the removal of dulex mesh.Per op notes, ¿several folds in the mesh were noted and this was likely the cause of pain.The mesh was completely explanted.A synthetic mesh was placed.¿.

• 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: 8961675
• Report Number: 1213643-2019-08298
• Device Sequence Number: 11380401
• Product Code: FTL
• UDI-Device Identifier: 00801741011849
• UDI-Public: (01)00801741011849(17)130528(10)BRSE8129
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K003917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 05/28/2013
• Device Catalogue Number: 0115191
• Device Lot Number: BRSE8129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 06/25/2025
• 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: Disability; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female