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

Catalog Number	5954450
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2014 - patient was diagnosed with multiple incisional hernias from the periumbilical region thereby underwent laparoscopic repair with implant of three ventralight st mesh (device 1, 2 and 3).Per op notes, "an incision was made in a transverse fashion in the epigastric region just to the left of midline.A small periumbilical hernia was identified.The hernia was present in the superficial layers of the abdominal wall.The adhesions were taken down.Another fascial defect was noted and the source of each of these hernias were cleared back.Defects were noted in the periumbilical area, right hemi-abdomen and midline lower abdomen.The ventralight st mesh (device 1) was placed to the right hemi-abdomen defect and secured with tack.The midline lower abdominal defect was closed in a similar fashion with an ventralight st mesh (device 2).The periumbilical area was covered with a second circular ventralight st mesh (device 3) and secured in with an outer crown and inner crown of tacks." (b)(6) 2018 - patient was diagnosed with recurrent umbilical hernia thereby underwent laparoscopic repair with excision of ventralight st mesh (device 3) and implant of unknown mesh.Per op notes, "a horizontal incision was made above the umbilicus.A small hernia sac was identified and dissected out down to the fascia.The defect was noted to be much larger than anticipated.The mesh (device 3) was identified in the preperitoneal space which had become dislodged and dissected out.The contents of the hernia sac was noted and the sac was excised.The omentum was reduced and the fascial defect was secured with suture.The abdominal wall in the lower abdomen was visualized.A large piece of mesh (device 1 and 2) was noted to be buckled in many locations but appeared to be intact.No evidence of recurrent hernia was noted.The mesh (device 1 and 2) appeared to be well incorporated into the abdominal wall.An unknown mesh was placed into the preperitoneal space and secured to the abdominal wall with sutures." (note: the mesh implanted in this procedure is unknown).
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-mar-2014) is considered to be a best estimate.This emdr represents the ventralight st mesh (device 1).An additional emdr and supplemental emdr were submitted to represent the ventralight st mesh (device 2) and ventralight st mesh (device 3).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 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 ; +1(800)556-6756
• MDR Report Key: 50053188
• Report Number: 1213643-2026-00959
• Device Sequence Number: 15857386
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618(17)160328(10)HUYC0935
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 03/28/2016
• Device Catalogue Number: 5954450
• Device Lot Number: HUYC0935
• 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: 07/21/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2014
• 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