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

Catalog Number	0110151
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	05/22/2012
Type of Reportable Event	Serious Injury
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 mdr represents the bard dulex mesh (device 1).An additional supplemental emdr was submitted to represent the ventralight st mesh (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
Per information provided: on (b)(6) 2010- patient was diagnosed with incisional hernia, thereby underwent laparoscopic repair with implant of bard dulex mesh (device 1).Per op notes, ¿the hernia sac was identified in the abdominal region and was dissected.A bard dulex mesh (device 1) was placed and sutured¿.On (b)(6) 2012- patient was diagnosed with incisional hernia, thereby underwent laparoscopic repair with implant of ventralight st mesh (device 2).Per op notes, ¿the hernia sac was identified in the right lower quadrant which was above the previously placed mesh (device 1).A ventralight st mesh (device 2) was cut and placed in the defect region and sutured¿.On (b)(6) 2013- patient was diagnosed with recurrent incisional hernia, thereby underwent laparoscopic repair with explant of bard dulex mesh (device 1), ventralight st mesh (device 2), implant of ventralight st mesh (device 3).Per op notes, ¿the recurrent hernia sac was identified in the abdominal region and was reduced.A ventralight st mesh (device 3) 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 59715
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 24380814
• Report Number: 1213643-2026-00177
• Device Sequence Number: 18764498
• Product Code: FTL
• UDI-Device Identifier: 00801741011795
• UDI-Public: (01)00801741011795(17)150428(10)BRUD0096
• 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: 2010
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

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: 04/28/2015
• Device Catalogue Number: 0110151
• Device Lot Number: BRUD0096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 53 YR
• Patient Sex: Female