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

Catalog Number	5955790
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Bowel Perforation (2668)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2007 - patient was diagnosed with umbilical and ventral hernia thereby underwent open repair with the implant of ventralex mesh (device 1).Per op notes, "the umbilicus was mobilized off the fascia.The hernia sac was opened and reduced back into the abdomen.A ventralex mesh (device 1) were placed through the defect against the abdominal wall using prolene sutures." on (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh using echo ps (device 2).Per op notes, "the small bowel which was densely adherent to the prior mesh (device 1) and suture material.A portion of the mesh and suture were left intact on the surface of the bowel and the bowel was mobilized; adhesions were taken down.A ventralight st mesh using echo ps (device 2) was placed in the abdominal cavity using tacks." on (b)(6)-2019 - patient was diagnosed with perforated small bowel and abscess thereby underwent repair with removal of mesh (device 1 and 2).Per op notes, "the patient had moderate abdominal pain.There was adjacent perforation to the mesh (device 1 and 2) where it had migrated into the small bowel.The previously placed mesh (device 1 and 2) were removed.".
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.This mdr represents the ventralight st mesh using echo ps (device 2).An additional supplemental emdr was submitted to represent the ventralex mesh (device 1).Note, the manufacturing date (15-aug-2018) is considered to be a best estimate.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: 50482728
• Report Number: 1213643-2026-01129
• Device Sequence Number: 13305384
• Product Code: FTL
• UDI-Device Identifier: 00801741031762
• UDI-Public: (01)00801741031762(17)200928(10)HUCV1967
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 08/20/2026

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: 09/28/2020
• Device Catalogue Number: 5955790
• Device Lot Number: HUCV1967
• 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: 08/15/2018
• 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 Sex: Male
• Patient Weight: 258 LB