MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 MESH - COMPOSIX L/P; SURGICAL MESH

Catalog Number	0134460
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	03/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per additional information provided: on (b)(6) 2014 ¿ patient was diagnosed with ventral incisional hernia thereby underwent laparoscopic repair with implant of composix lp mesh (device 1) and ventrio mesh (device 2).Per operative notes, ¿the defect was measured, and an oval composix lp mesh (device 1) was placed and sutured into the abdominal cavity.A ventrio mesh (device 2) was placed for additional coverage to cover the lower edge of the defect.¿ on (b)(6) 2016 ¿ patient had mesh migration, hernia recurrence thereby underwent open repair with removal of meshes (device 1 and device 2).Per operative notes, ¿the hernia sac which contained a wadded up matted large mesh (device 1 and device 2) adherent to bowel walls and omentum.Adhesions were lysed.The meshes (device 1 and device 2) were excised.The hernia defect was measured and repaired using sutures.¿.
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.Note, the manufacturing date (15-dec-2013) is considered to be a best estimate.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 - COMPOSIX L/P
• 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): 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 ; 8005566756
• MDR Report Key: 23422927
• Report Number: 1213643-2025-01038
• Device Sequence Number: 8253098
• Product Code: FTL
• UDI-Device Identifier: 00801741031274
• UDI-Public: (01)00801741031274(17)181228(10)HUXL0194
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

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: 12/28/2018
• Device Catalogue Number: 0134460
• Device Lot Number: HUXL0194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2013
• 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: 39 YR
• Patient Sex: Female