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 Code	Hernia (2240)
Date of Event	08/24/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2014 - patient was diagnosed with periumbilical ventral hernia thereby underwent laparoscopic repair with the implant of ventrio st mesh (device 1).Per op notes, "a ventrio st mesh (device 1) was placed into the abdominal cavity, secured over the hernia defect and umbilicus with the tacks." on (b)(6) 2015 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the removal of mesh (device 1) and implant of ventralight st mesh using echo ps (device 2).Per op notes, "a lot of omental adhesions to previous mesh that was removed.There was herniation around the peripheral edge of mesh; the previous mesh (device 1) was removed.A ventralight st mesh using echo ps (device 2) was placed to the abdominal cavity using sutures." on (b)(6) 2016 - patient had abdominal wall defect thereby underwent abdominal wall reconstruction with bilateral myofascial flaps.Per op notes, "the anterior abdominal wall fascia was encountered.The mesh removal would carry the excessive morbidity for the patient.Therefore, the previously placed mesh (device 2) was left in place.A biologic mesh was then placed.".
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 emdr represents the ventralight st mesh using echo ps (device 2).An additional supplemental emdr was submitted to represent the ventrio st (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: 50114027
• Report Number: 1213643-2026-01002
• Device Sequence Number: 15962644
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755(17)160828(10)HUYG1605
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: 08/28/2016
• Device Catalogue Number: 5955680
• Device Lot Number: HUYG1605
• 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: 07/28/2026
• Initial Report FDA Received Date: 08/03/2026
• 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 Sex: Female