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

Catalog Number	5954460
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2015 - patient was diagnosed with bilateral inguinal hernias, umbilical hernia, thereby underwent laparoscopic repair with implant of bard flat mesh (device 1 and 2).Per op notes, ¿a direct inguinal hernia was identified in the left inguinal region and was dissected.A bard flat mesh (device 1) was placed in the defect region and sutured.A small indirect hernia was identified in the right inguinal region and was reduced.A bard flat mesh (device 2) was placed and secured in posterior abdominal wall.Another hernia was identified in umbilical region, dissected and sutured¿.On (b)(6) 2017- patient was diagnosed with recurrent ventral hernia, thereby underwent laparoscopic repair with implant of ventrio st mesh (device 3).Per op notes, ¿incision was made through old scar which was partially excised.The hernia defect was then identified through the abdominal wall tissues.A ventrio st mesh (device 3) was placed and sutured¿.On (b)(6) 2017- patient was diagnosed with recurrent incisional hernia, thereby underwent open repair with implant of ventralight st mesh (device 4) and explant of ventrio st mesh (device 3).Per op notes, ¿the scar tissue was removed.There were omental adhesions to the mesh and was taken down, ventrio st mesh (device 3) was found to be pulled away from left side of the abdominal wall and the entire ventrio st mesh (device 3) was dissected and sutured.A ventralight st mesh was placed to fit the open area in the abdomen and sutured¿.On (b)(6) 2018- patient was diagnosed with abdominal pain, thereby underwent right transverse abdominus plane (tap) block.
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-jun-2017) is considered to be a best estimate.This mdr represents the ventralight st mesh (device 4).An additional supplemental emdr was submitted to represent the ventrio 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 ; 8005566756
• MDR Report Key: 23725966
• Report Number: 1213643-2025-01163
• Device Sequence Number: 13419044
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(17)190728(10)HUBT2578
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• 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): 12/03/2025

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: 07/28/2019
• Device Catalogue Number: 5954460
• Device Lot Number: HUBT2578
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2017
• 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: 41 YR
• Patient Sex: Male