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	Abdominal Pain (1685); Adhesion(s) (1695)
Date of Event	10/26/2021
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-2018) is considered to be a best estimate.This emdr 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: on (b)(6) 2014 - patient was diagnosed with epigastric hernia thereby underwent open repair with implant of ventralex st mesh (device 1).Per op notes, "an incision was made in the low epigastrium.An incisional and umbilical hernia were identified.Both the defects were made as one defect which was repaired by placing a ventralex st mesh (device 1) and secured with sutures to the fascial edge." on (b)(6) 2018 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with excision of ventralex st mesh (device 1) and implant of ventralight st with echo ps (device 2).Per op notes, "a small transverse incision was made.Adhesions were taken down between the omentum and the undersurface of the old hernia mesh (device 1).The old mesh was removed and bisected, there were two fascial defects.A ventralight st with echo ps (device 2) was placed into the peritoneal cavity and secured at its edges and at scattered sites towards the middle with the absorbable tacks." on (b)(6) 2021 - patient was diagnosed with abdominal pain thereby underwent laparoscopic repair.Per op notes, "intra-abdominal lysis of adhesions was made.Adhesions between the omentum and transverse mesocolon to the anterior abdominal wall mesh was taken down.The previously placed ventralight st using echo ps mesh (device 2) appeared to be intact with no recurrent hernia.No mesh removal was performed.".

• 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: 25717288
• Report Number: 1213643-2026-00869
• Device Sequence Number: 13423027
• Product Code: FTL
• UDI-Device Identifier: 00801741031724
• UDI-Public: (01)00801741031724(17)200928(10)HUCV1965
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: 09/28/2020
• Device Catalogue Number: 5955460
• Device Lot Number: HUCV1965
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2018
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 83 KG