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

Catalog Number	0114115
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	12/20/2006
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 emdr represents the bard reconix mesh (device 1).An additional supplemental emdr and emdr were submitted to represent the reconix mesh (device 2) and 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.
Event or Problem Description
Per information provided: on (b)(6) 2004 ¿ patient was diagnosed with recurrent right flank ventral hernia thereby underwent laparoscopic repair with implant of reconix mesh (device 1).Per operative notes, ¿multiple adhesions were taken down.A reconix mesh (device 1) was placed and sutured into the defect.¿ on (b)(6) 2004 ¿ patient was diagnosed with right flank recurrent hernia thereby underwent open repair with implant of reconix mesh (device 2) and bard flat mesh (device 3).Per operative notes, ¿the scar tissue was excised.The old reconix mesh (device 1) was identified, and dissection revealed a hernia.The hernia sac was dissected.In the peritoneal side of the hernia, a reconix mesh (device 2) was placed and sutured.A bard flat mesh (device 3) was placed and tacked.¿ on (b)(6) 2006 ¿ patient was diagnosed with right flank recurrent incisional hernia thereby underwent open repair with removal of meshes (device 1, 2, 3) and an implant of dulex mesh (device 4).Per operative notes, ¿a significant adhesiolysis of the right colon that was adhered to the hernia sac itself.There was another prior mesh was seen that seemed to have had fallen away from part of the wall.The multiple gore-tex sutures that were used to place the prior meshes (device 1, 2, 3) were removed.A dulex mesh (device 4) was placed and sutured.¿.

• Brand Name: RECONIX
• 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: 23553281
• Report Number: 1213643-2025-01095
• Device Sequence Number: 13205431
• Product Code: FTL
• UDI-Device Identifier: 00801741011818
• UDI-Public: (01)00801741011818(10)41GMBR08
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K003906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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: 0114115
• Device Lot Number: 41GMBR08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/14/2025
• 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: 45 YR
• Patient Sex: Female