MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Ventralight ST w/ Echo; Surgical Mesh

Catalog Number	5955680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bowel Perforation (2668)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2014 - patient was diagnosed with small bowel obstruction, internal hernia, adhesion, incisional hernia thereby underwent open repair with the implant of bard flat mesh (device 1).Per op notes, "a midline incision was undertaken from the infraumbilical to suprapubic region in the midline.Bands of adhesion causing an internal hernia and twisting of the small bowel adjacent to the hernia consistent with small bowel obstruction as noted.A lightweight bard flat mesh (device 1) was placed as an only over the fascia and secured using sutures." on (b)(6) 2017 - patient was diagnosed with multiple ventral hernias thereby underwent robot assisted repair with the implant of ventralight st mesh using echo (device 2).Per op notes, "a ventral hernia in the midline near the umbilical region was identified.Nine abdominal wall hernias was noted.A ventralight st mesh using echo (device 2) was placed into the defect and secured using tacks." on (b)(6) 2017 - patient had hiatal hernia, intraabdominal adhesion, bowel stuck to mesh, perforation thereby underwent repair.(note: there is no op notes provided for this procedure in medical records).
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 ((b)(6) 2016) is considered to be a best estimate.This emdr represents the ventralight st mesh using echo (device 2).An additional supplemental emdr was submitted to represent the bard flat 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.

• 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 ; +1(800)556-6756
• MDR Report Key: 50479623
• Report Number: 1213643-2026-01128
• Device Sequence Number: 18670080
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755(17)180728(10)HUAU1312
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• 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): 08/21/2026

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: 07/28/2018
• Device Catalogue Number: 5955680
• Device Lot Number: HUAU1312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2016
• 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: Life Threatening; Required Intervention
• Patient Sex: Female