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

Catalog Number	0110151
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240)
Date of Event	05/25/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2007 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of two composix l/p (device # 1 & # 2).Per op notes, ¿two composix l/p mesh (device #1 & #2) were placed within the abdomen and tacked to the left aspect of the hernia using sutures.¿ (b)(6) 2009 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of dulex mesh (device # 3).Per op notes, ¿omental adhesions were taken down.A dulex mesh (device # 3) was placed in the abdomen and tacked to the overlying peritoneum using sutures.¿ (note: there is no mention/visualization of previously placed composix l/p (device #1 & #2) during this repair).(b)(6) 2011 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of ventralex mesh (device #4).Per op notes, ¿a small defect was noted in the left lower quadrant where two previous placed meshes (device # 1 & # 2) come together.A ventralex mesh (device #4) was placed in the abdomen and tacked over to overlie the defect.¿ (note: there is no mention/visualization of previously placed dulex mesh (device # 3) during this repair).(b)(6) 2012 - patient was diagnosed with infected mesh from incisional hernia thereby underwent repair with removal of mesh (device #1, #2, #3 & #4).Per op notes, ¿the abdomen was entered, and a large piece of mesh was encountered and an extensive adhesiolysis was performed.The mesh (device #1, #2, #3 & #4) was then removed.There was noted to be an abscess cavity in the lateral left aspect of the mesh.¿.
Additional Manufacturer Narrative
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.This emdr represents the bard/davol mesh ¿ dulex (device #3).Additional supplemental emdr's were submitted to represent the bard/davol mesh ¿ composix l/p (device #1 & #2) and bard/davol mesh ¿ ventralex (device #4).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: SURGIAL 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: 22021480
• Report Number: 1213643-2025-090208
• Device Sequence Number: 20993021
• Product Code: FTL
• UDI-Device Identifier: 00801741011795
• UDI-Public: (01)00801741011795(17)131128(10)BRSK8315
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K003917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: 11/28/2013
• Device Catalogue Number: 0110151
• Device Lot Number: BRSK8315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/14/2025
• 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: 49 YR
• Patient Sex: Female