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

Catalog Number	0123810
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2015 - patient was diagnosed with ventral incisional hernia thereby underwent laparoscopic repair with implant of ventralight st using echo ps (device 1) and composix e/x (device 2).Per op notes, ¿a large hernia sac was identified and reduced.A ventralight st using echo ps (device 1) and a composix e/x (device #2) was placed and sutured using sorbafix absorbable tacks.¿ (b)(6) 2020 - patient was diagnosed with recurrent ventral incisional hernia with abdominal pain thereby underwent robotic assisted laparoscopic repair with excision of ventralight st using echo ps (device 1), composix e/x (device 2) and implant of ventralight st using echo ps 2 (device 3).Per op notes, ¿extensive adhesions were note and lysed.The prior mesh (device 1 and 2) identified to be rippled and folded back itself and the superior edge of mesh had come loose.The entire mesh (device 1 and 2) was excised and removed.The hernia defect was identified and reduced.A ventralight st using echo ps 2 (device 3) was placed and sutured.¿.
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-dec-2014) is considered to be a best estimate.This emdr represents the bard mesh - composix e/x (device 2).Additional supplemental emdrs were submitted to represent the bard ventralight st w/ echo (device 1) and bard ventralight st w/ echo 2 (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 E/X
• 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: 22920813
• Report Number: 1213643-2025-00800
• Device Sequence Number: 15743778
• Product Code: FTL
• UDI-Device Identifier: 00801741031212
• UDI-Public: (01)00801741031212(17)191228(10)HUYL0426
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• 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: 12/28/2019
• Device Catalogue Number: 0123810
• Device Lot Number: HUYL0426
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2014
• 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: 31 YR
• Patient Sex: Male
• Patient Weight: 132 KG