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	09/08/2017
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-jun-2015) is considered to be a best estimate.This mdr represents the ventralight st (device 2).An additional supplemental emdr was submitted to represent the ventralight st with echo ps (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: (b)(6) 2015 - patient was diagnosed with epigastric and umbilical hernia thereby underwent laparoscopic repair with implant of ventralight st with echo ps (device 1) and ventralight st mesh (device 2).Per op notes, ¿a right lower quadrant stab incision was made.Omental adhesions in the midline and the hernia omentum was reduced and taken down.A left upper quadrant stab incision was made.A ventralight st with echo ps (device 1) was placed in the hernia defects where 3 small incisions were made in the epigastric region over the epigastric hernia and secured with metal tacker.Another small incision was made over the umbilicus.Inferiorly at the umbilicus the overlap was not 2 cm so a ventralight st mesh (device 2) was placed and anchored to the abdominal wall with sutures.¿ (b)(6) 2017 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with excision of ventralight st with echo ps (device 1) and ventralight st mesh (device 2) and implant of ventrio st mesh (device 3).Per op notes, ¿midline incision was made and the hernia sac was opened and excised.Small hernias were identified superiorly and inferiorly.Old mesh (device 1 and 2) present around the left lateral aspect of the wound was taken off the abdominal wall and the abdominal fascia had been shredded by the tacks.A ventrio st mesh (device 3) was placed posterior to the abdominal fascia and secured with sutures and tacks.¿.

• 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: 24686052
• Report Number: 1213643-2026-00361
• Device Sequence Number: 13174925
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(17)170728(10)HUZF1133
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: 07/28/2017
• Device Catalogue Number: 5954460
• Device Lot Number: HUZF1133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2015
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 98 KG