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

Catalog Number	5954810
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2019 - patient was diagnosed with incarcerated umbilical hernia with small bowel obstruction thereby underwent open repair with implant of ventralight st mesh (device 1).Per operative notes, "an incision was made above the umbilicus down towards the umbilicus.Near the umbilicus area the hernia sac was identified and taken down sharply.A ventralight st mesh (device 1) was placed into the defect and closed the defect with sutures." on (b)(6) 2019 - patient was diagnosed with small bowel obstruction, adhesions thereby underwent laparoscopic repair with implant of abdominal lysis of adhesions and release of small bowel obstruction.Per operative notes, "an incision was made into the umbilical region.There were some adhesions in the anterior abdominal wall which were taken down sharply.The small bowel obstructions were then released from abdomen.The defect was closed with sutures." on (b)(6 )2020 - patient was diagnosed with recurrent incisional hernia, thereby underwent robotic assisted laparoscopic repair with implant of ventralight st mesh (device 2).Per operative notes, "a transverse incision was made in the left upper quadrant.The hernia sac was dissected out.There were no significant adhesions to the abdominal wall.A ventralight st mesh (device 2) was placed into the peritoneal cavity and secured it with sutures." on (b)(6) 2023 - patient was diagnosed with recurrent ventral incisional hernia, adhesions, scar tissue thereby underwent open repair with implant of phasix st mesh (device 3) and explant of ventralight st mesh (device 1 & 2).Per operative notes, "a vertical midline incision was made through old incision.The hernia sac was dissected out.Some dense adhesions were taken down sharply from the abdominal cavity.There was some scar tissues present with old meshes ventralight st mesh (device 1 & 2).Both meshes (device 1 & 2) were excised entirely.A phasix st mesh (device 3) was placed into the lateral abdominal wall and secured it with sutures.".
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-dec-2018) is considered to be a best estimate.This emdr represents the ventralight st mesh (device 2).An additional supplemental emdr was submitted to represent the ventralight st mesh (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 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: 50260299
• Report Number: 1213643-2026-01041
• Device Sequence Number: 13295893
• Product Code: FTL
• UDI-Device Identifier: 00801741031687
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 01/28/2021
• Device Catalogue Number: 5954810
• Device Lot Number: HUCZ1113
• 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: 08/05/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2018
• 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: 244 LB