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

Catalog Number	5955460
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	11/02/2017
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-jul-2016) is considered to be a best estimate.This mdr represents the ventralight st w/ echo mesh (device 2).An additional supplemental emdr was submitted to represent the ventralex 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.
Event or Problem Description
Per information provided: (b)(6) 2012 - patient was diagnosed with ventral hernia thereby underwent open repair with implant of ventralex st mesh (device 1).Per operative notes, ¿an incision was made over the hernia through skin.The hernia sac was dissected out.A large ventralex st mesh (device 1) was placed into the defect and secure it with sutures.¿ (b)(6) 2016 ¿ patient was diagnosed with recurrent ventral incisional hernia, adhesion, thereby underwent laparoscopic repair with explant of ventralex st mesh (device 1) and implant of ventralight st w/ echo mesh (device 2).Per operative notes, ¿an incision was made into the preperitoneal space.The hernia sac was dissected out.All adhesions were taken down.Previously placed ventralex st mesh (device 1) was carefully freed and excised entirely.A ventralight st w/ echo mesh (device 2) was placed into the defect and closed with sutures.¿ (b)(6) 2017 - patient was diagnosed with large recurrent ventral hernia, adhesion, scar tissue, thereby underwent laparoscopic repair with explant of ventralight st w/ echo mesh (device 2) and implant of bard soft mesh (device 3).Per operative notes, ¿an incision was made along the midline following previous scar through the entire length of the hernia.The hernia sac was dissected out.Previously placed ventralight st w/ echo mesh (device 2) was excised.There was dense amount of adhesions which was taken down.A bard soft mesh (device 3) was placed into the preperitoneal space and secure it with sutures.¿.

• 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 ; 8005566756
• MDR Report Key: 24504678
• Report Number: 1213643-2026-00279
• Device Sequence Number: 10456315
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724(17)180728(10)HUAU0184
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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: 07/28/2018
• Device Catalogue Number: 5955460
• Device Lot Number: HUAU0184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2016
• 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: 67 YR
• Patient Sex: Male