MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH; SURGICAL MESH

Catalog Number	5954460
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/15/2016
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-2014) is considered to be a best estimate.This mdr represents the ventralight st mesh (device 2).An additional supplemental emdr was submitted to represent the ventrio 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.
Event or Problem Description
Per information provided: on (b)(6) 2014 - patient was diagnosed recurrent incisional hernia, adhesion thereby underwent open repair with allomax surgical graft (device 1) and ventralight st mesh (device 2).Per operative notes, ¿an incision was made through previous scar.Previously placed synthetic mesh was excised.A piece of allomax surgical graft (device 1) was placed into the abdominal cavity and tacked with sutures.A ventralight st mesh (device 2) was placed with allomax surgical graft (device 1) and secure both meshes with sutures.¿ on (b)(6) 2016 - patient was diagnosed with incarcerated incisional ventral hernia thereby underwent open repair with implant of ventrio st mesh (device 3).Per operative notes, ¿an incision was made into the left lower quadrant.An incarcerated incisional recurrent ventral hernia sac was present in the left lower abdominal wall, which was excised.A ventrio st mesh (device 3) was deployed for the entire area and tacked into the abdominal wall.¿ on (b)(6) 2017 - patient was diagnosed with incarcerated recurrent incisional ventral hernia, adhesion thereby underwent open repair with implant of ventralex st mesh (device 4).Per operative notes, ¿an incision was made supraumbilical region.There was dense number of adhesions, which were taken down.The hernia sac was dissected out.A ventralex st mesh (device 4) was placed into the abdominal wall and secure it with tackers.¿.

• Brand Name: VENTRALIGHT ST MESH
• 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: 24444423
• Report Number: 1213643-2026-00215
• Device Sequence Number: 10443625
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(17)160728(10)HUYG0037
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: 07/28/2016
• Device Catalogue Number: 5954460
• Device Lot Number: HUYG0037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2014
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 86 KG