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

Catalog Number	0134460
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2017 ¿ patient was diagnosed with incarcerated umbilical hernia thereby underwent laparoscopic repair with the implant of composix l/p mesh (device #1).Per operative notes, ¿a piece of composix l/p mesh (device #1) was placed on the skin of the anterior abdominal wall using sorbafix tackers.¿ on (b)(6) 2017 ¿ patient was recurrent incarcerated ventral incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh (device #2).Per operative notes, ¿the adhesions to anterior abdominal wall near the hernia defect and mesh (device #1).The adhesions were lysed.A ventralight st mesh (device #2) was placed in the middle and centered over the hernia defect using tacker.¿ on (b)(6) 2017 ¿ patient was diagnosed with reducible ventral hernia thereby underwent open repair.Per operative notes, ¿the hernia was in subxiphoid region.The previously placed mesh (device #1, #2) was encountered.The overlying mesh (device #1) had moved apart somewhat.¿ on (b)(6) 2018 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of ventralight st mesh (device #3).Per operative notes, ¿adhesions of omentum to the colon and mesh were lysed.The previously placed mesh (device #1, #2) in the subxiphoid region had shifted to the left somewhat and there was a recurrence at the midline just to the right of the mesh.A piece of ventralight st mesh (device #3) laid to cover the hernia defect using optifix tackers.¿.
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-oct-2016) is considered to be a best estimate.This emdr represents the bard mesh - composix l/p (device 1).Additional supplemental emdrs were submitted to represent the bard ventralight st mesh (device 2) and bard ventralight st mesh (device 3).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: 22911097
• Report Number: 1213643-2025-00796
• Device Sequence Number: 18446866
• Product Code: FTL
• UDI-Device Identifier: 00801741031274
• UDI-Public: (01)00801741031274(17)210928(10)HUAX0064
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: 09/28/2021
• Device Catalogue Number: 0134460
• Device Lot Number: HUAX0064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2016
• 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: 58 YR
• Patient Sex: Female