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

Catalog Number	5955450
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	09/03/2019
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-nov-2016) is considered to be a best estimate.This emdr represents the ventralight st w/ echo mesh (device 2).An additional supplemental emdr was submitted to represent the ventralight st w/ echo mesh (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) 2017 - patient was diagnosed with multiple incisional ventral hernia thereby underwent robotic assisted laparoscopic repair with implant of ventralight st w/ echo mesh (device 1 and device 2).Per operative notes, "a midline incision was made in the epigastric region.All hernia sacs were taken down sharply.One ventralight st w/ echo mesh (device 1) was placed into the epigastric region.2nd piece of ventralight st w/ echo mesh (device 2) was placed in the suprapubic midline region and secured it with sutures." (b)(6) 2019 - patient was diagnosed with recurrent ventral hernia, pain thereby underwent open repair with explant of ventralight st w/ echo mesh (device 1 and device 2).Per operative notes, "an incision was made into the peritoneal cavity.The hernia sac was dissected out.Previously placed mesh (device 1 and device 2) had bunched up beyond the level of the fascia.Both (device 1 and 2) had almost stretched or become mispositioned to be convex from the abdominal wall fascia.Both ventralight st w/ echo mesh (device 1 and device 2) was totally excised.".

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 25334080
• Report Number: 1213643-2026-00694
• Device Sequence Number: 18630473
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717(17)181128(10)HUAY1437
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: 11/28/2018
• Device Catalogue Number: 5955450
• Device Lot Number: HUAY1437
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2016
• 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: 71 YR
• Patient Sex: Female