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

Catalog Number	0134610
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930)
Date of Event	08/07/2013
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-jul-2009) is considered to be a best estimate.This emdr represents the bd mesh - composix l/p (device 1).An additional supplemental emdr was submitted to represent the bd ventrio 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: (b)(6) 2010 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of composix l/p mesh (device 1) and ventrio mesh (device 2).Per operative notes, ¿a right upper quadrant incision was made and carried down to the fascia.Hernia sac was dissected out.A large composix l/p mesh (device 1) was placed in the defect and tacked with absorbable tackers.A ventrio mesh (device 2) was placed in the midline designed for the midline incision and tacked with tackers.¿ (b)(6) 2013 - patient was diagnosed with infected mesh with small bowel fistula thereby underwent open repair with implant of allomax mesh (device 3) and explant of composix l/p mesh (device 1) and ventrio mesh (device 2).Per operative notes, ¿a midline incision was made.Small bowel fistula was removed.Previously placed infected composix l/p mesh (device 1) and ventrio mesh (device 2) were removed entirely.A allomax mesh (device 3) was placed in the defect and secure it with sutures.¿.

• 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: 23474568
• Report Number: 1213643-2025-01066
• Device Sequence Number: 13319196
• Product Code: FTL
• UDI-Device Identifier: 00801741031281
• UDI-Public: (01)00801741031281(17)140928(10)HUTG0323
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• 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): 11/03/2025

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: 09/28/2014
• Device Catalogue Number: 0134610
• Device Lot Number: HUTG0323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2009
• 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; Disability
• Patient Age: 64 YR
• Patient Sex: Female