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 Codes	Abscess (1690); Adhesion(s) (1695); Scar Tissue (2060); Seroma (2069); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
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-aug-2017) is considered to be a best estimate.This emdr represents the ventralight st mesh (device 1).An additional supplemental emdr was submitted to represent the ventralight st mesh (device 2).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.
Event or Problem Description
Per information provided: (b)(6) 2017 - patient was diagnosed with parastomal hernia thereby underwent open repair with implant of ventralight st mesh (device 1).Per operative notes, "a long midline skin incision was made and brought down sharply through fascia.There was some previously placed mesh identified which was intact.There were several adhesions.The hernia sac was dissected out.A ventralight st mesh (device 1) was placed into the abdominal cavity and secured it with sutures." (b)(6) 2018 - patient was diagnosed with recurrent parastomal hernia with partial obstruction, seroma, adhesion, thereby underwent open repair with implant of ventralight st mesh (device 2).Per operative notes, "a midline incision was made through old incision site.The hernia sac was dissected out.There was a small chronic seroma in the midportion of the wound.There was some moderate number of adhesions in the small bowel to the midline wound, all adhesions were taken down sharply.There was small bowel, which was obstructive, all obstructions were taken down.Previously placed ventralight st mesh (device 1) was identified.A ventralight st mesh (device 2) was placed into the abdominal wall and secured it with sutures." (b)(6) 2018 - patient was diagnosed with non-healing surgical wound; scar tissue thereby underwent open repair with debridement of wound and explant of ventralight st mesh (device 1) and ventralight st mesh (device 2) and unknown mesh and primary repair.Per operative notes, "an incision was made through old incision site.Dense number of scar tissue present into the umbilicus.Part of the old meshes ventralight st mesh (device 1 and 2) was excised.Non-healing wound which was present into the umbilicus.The wound was debridement and excised.The defect was closed with sutures primarily." (b)(6) 2019 to (b)(6) 2019 - patient was diagnosed with ventral abdominal wall abscess, parastomal fluid thereby underwent revision repair with drainage of abscess cavity.

• 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: 50588121
• Report Number: 1213643-2026-01151
• Device Sequence Number: 9451448
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(17)190728(10)HUBV0056
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: 07/28/2019
• Device Catalogue Number: 5954460
• Device Lot Number: HUBV0056
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2017
• 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 Sex: Male