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

Catalog Number	0134450
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	12/28/2009
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-apr-2009) is considered to be a best estimate.This mdr represents the composix l/p mesh (device 2).An additional supplemental emdr was submitted to represent the composix l/p mesh (device 1).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) 2009 ¿ patient was diagnosed with left lower quadrant incisional hernia thereby underwent laparoscopic repair with implant of two composix l/p meshes (device 1 and 2).Per operative notes, ¿ in the left lower quadrant, a large hernia with scar was noted.Adhesions were lysed and oval composix l/p mesh (device 1) was placed, and another circular composix l/p mesh (device 2) was placed as an adequate coverage and connected together with sutures and tacks." on (b)(6) 2009 ¿ patient was diagnosed with recurrent left lower quadrant incisional hernia thereby underwent open repair with removal of prior meshes (device 1 and 2) implant of biological graft.Per operative notes, ¿ a small hernia sac was identified inferior to the meshes (device 1 and 2).The meshes (device 1 and 2) were separated from the anterior abdominal wall and completely removed.Several areas of adhesions were lysed.The biological graft was placed in an underlay fashion and secured to anterior abdominal wall 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: 24326890
• Report Number: 1213643-2026-00124
• Device Sequence Number: 9966620
• Product Code: FTL
• UDI-Device Identifier: 00801741031267
• UDI-Public: (01)00801741031267(17)140428(10)HUTD0055
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 04/28/2014
• Device Catalogue Number: 0134450
• Device Lot Number: HUTD0055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2009
• 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
• Patient Age: 64 YR
• Patient Sex: Female