MAUDE Adverse Event Report: BRIDGER BIOMED, INC. -3031159 MESH ¿ DULEX; SURGICAL MESH

Catalog Number	0126342
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	10/30/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2001 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with implant of composix mesh (device #1).Per operative notes, ¿the hernia sac was dissected, and a composix mesh (device #1) was placed and sutured." (b)(6) 2006 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent laparoscopic repair with implant of dulex mesh (device #2).Per operative notes, ¿lysis of adhesions was performed.A dual mesh (device #2) was placed and tacked." (b)(6) 2007 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with explant of composix mesh (device #1) and implant of biological mesh.Per operative notes, ¿the mesh (device #1) was found disrupted from the anterior abdominal wall was excised completely and removed.The mesh (device #2) on the right side was found in good position.A biological mesh was placed and sutured." (b)(6) 2008 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with explant of dulex mesh (device #2) and biological mesh.Per operative notes, ¿the hernia sac was reduced.Lysis of adhesions was performed.The mesh (device #2) and biological mesh found disrupted over the defect were dissected and removed." (b)(6) 2009 - patient was diagnosed with multiple recurrent ventral hernias and right sided spigelian hernia thereby underwent open repair with implant of bard flat mesh (device #3).Per operative notes, ¿lysis of adhesions was performed.A bard flat mesh (device #3) was placed to cover all the defect and sutured." attorney alleges that the patient had adhesions, bowel perforation, mesh migration, pain and hernia recurrence.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 1year 8 months post implant of mesh ¿ dulex, patient was diagnosed with hernia recurrence, adhesions and mesh deformation thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the mesh ¿ dulex (device #2).An additional supplemental emdr was submitted to represent the mesh ¿ composix (device #1) and an additional emdr was submitted to represent the bard flat mesh(device #3).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.

• Brand Name: MESH ¿ DULEX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): BRIDGER BIOMED, INC. -3031159; 2430 north 7th avenue; bozeman MT 59715
• 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 ; 4018258495
• MDR Report Key: 21696076
• Report Number: 1213643-2025-090136
• Device Sequence Number: 15636028
• Product Code: FTL
• UDI-Device Identifier: 00801741011924
• UDI-Public: (01)00801741011924
• 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: 2006
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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 Catalogue Number: 0126342
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/26/2025
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 118 KG