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

Catalog Number	0115192
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient¿s attorney and review of patient medical records on (b)(6) 2007: patient was diagnosed with ventral and umbilical hernia thereby underwent open repair with the implant of composix kugel (device #1).Per operative notes, ¿a ventral hernia sac was reduced and pushed back.The umbilical sac also reduced.Both defects were then covered with an composix kugel (device #1) and tacked." on (b)(6) 2008: patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with the explant of composix kugel (device #1) and implant of composix kugel (device #2).Per operative notes, ¿the hernia sac noted to the left of midline was excised.The previously placed mesh (device #1) displaced laterally to the right was excised and removed completely.A composix kugel (device #2) was placed and tacked." on (b)(6) 2011: patient was diagnosed with bowel obstruction secondary to wadded up mesh (device #2) thereby underwent partial explant of composix kugel (device #2).Per operative notes, ¿the mesh (device #2) had become folded over upon itself and there were dense adhesions of small bowel at focal point of obstruction.Adhesions were taken down.The mesh (device #2) on the abdominal wall side was excised, the mesh on the opposite side appeared to be intact was left.On (b)(6) 2014: patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with the implant of dulex mesh (device #3).Per operative notes, ¿some remnant of old mesh (device #2) appeared to be well incorporated.Adhesiolysis was performed, all fascial defects were exposed, and a dulex mesh (device #3) was placed and sutured." on (b)(6) 2017: patient was diagnosed with recurrent ventral incisional hernia thereby underwent repair.Per operative notes, ¿adhesions around the hernia are removed and a primary repair was done using sutures." on (b)(6) 2019: patient was diagnosed with multiple abdominal wall recurrent hernias thereby underwent laparoscopic repair with the explant of composix kugel (device #2) and dulex mesh (device #3) and implant of two ventralight st mesh (device #4 & device #5).Per operative notes, ¿the previously placed meshes (device #2 & #3) were completely dissected away and removed.Adhesions were taken down.A large hernia in the right lower quadrant was placed obliquely with ventralight st mesh (device #4) and sutured.A second ventralight st mesh (device #5) was placed superiorly where subxiphoid hernia is present and sutured." attorney alleges that the patient had adhesions, bowel obstruction, bowel perforation, mesh migration, pain, hernia recurrence, mesh folded and mesh removal.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 4 years 9 months post implant of dulex mesh, patient was diagnosed with hernia recurrence and adhesions thereby underwent removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.This emdr represents the mesh ¿ dulex (device #3).Additional supplemental emdr's were submitted to represent the mesh ¿ composix kugel (device #1 & #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.

• 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): 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: 21879150
• Report Number: 1213643-2025-090163
• Device Sequence Number: 12921902
• Product Code: FTL
• UDI-Device Identifier: 00801741011856
• UDI-Public: (01)00801741011856(10)BRXI0017
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K003917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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: 0115192
• Device Lot Number: BRXI0017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/22/2025
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 127 KG