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

Catalog Number	0144680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	03/05/2019
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.Note, the manufacturing date (15-july-2011) is considered to be a best estimate.This emdr represents the bard mesh - composix l/p w/ echo (device 1).An additional supplemental emdr was submitted to represent the bard mesh - composix l/p (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: (b)(6) 2012 - patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with implant of composix l/p mesh with echo (device 1) and composix l/p mesh (device 2).Per op notes, "a composix l/p mesh with echo (device 1) and composix l/p mesh (device 2) were placed into the anterior abdominal wall using tacks." (b)(6) 2019 - patient was diagnosed with multiple recurrence of ventral hernia and extensive lysis of adhesions thereby underwent repair with removal of old mesh (device 1 and device 2).Per op notes, "lysis of adhesions was performed.The entire old meshes (device 1 and device 2) were removed.Dissection was carried to the dense scar tissue.A synthetic mesh was placed.".

• Brand Name: MESH - COMPOSIX L/P W/ ECHO
• 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: 22975579
• Report Number: 1213643-2025-00816
• Device Sequence Number: 15687829
• Product Code: FTL
• UDI-Device Identifier: 00801741031359
• UDI-Public: (01)00801741031359(17)120828(10)HUVG1706
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 09/02/2025

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: 08/28/2012
• Device Catalogue Number: 0144680
• Device Lot Number: HUVG1706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2011
• 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