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	Device Appears to Trigger Rejection (1524); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	05/28/2020
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-sep-2018) 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: the attorney firm representing the patient is located in puerto rico; however, the mesh was implanted in the u.S., and the adverse event also occurred in the u.S.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) 2019- patient was diagnosed with incisional hernia thereby underwent open repair with implant of composix l/p mesh (device 1).Per op notes, ¿the hernia sac was identified in the umbilical region and dissected.A composix l/p mesh (device 1) was placed and sutured¿.(b)(6) 2019 - patient was diagnosed with recurrent incisional hernia, thereby underwent laparoscopic repair with adhesiolysis, explant of composix l/p mesh (device 1), implant of composix l/p mesh (device 2).Per op notes, ¿recurrent hernia was identified in umbilical region and the prior mesh (device 1) was excised.A new composix l/p mesh (device 2) was placed and sutured circumferentially¿.(b)(6) 2020- patient was diagnosed with incisional hernia with dense intra-abdominal adhesions, thereby underwent laparoscopic repair with implant of synthetic mesh.Per op notes,¿ dense adhesions were taken down.The prior mesh (device 2) was found to be pulled away from left side.Eventration of mesh was noted.A synthetic mesh was placed in the abdominal cavity and tacked.¿.

• 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: 24698699
• Report Number: 1213643-2026-00376
• Device Sequence Number: 13371911
• Product Code: FTL
• UDI-Device Identifier: 00801741031274
• UDI-Public: (01)00801741031274(17)230928(10)HUCW1974
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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: 09/28/2023
• Device Catalogue Number: 0134460
• Device Lot Number: HUCW1974
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2018
• 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: 61 YR
• Patient Sex: Female