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

Catalog Number	5955680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Adhesion(s) (1695)
Date of Event	01/03/2017
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-jun-2013) is considered to be a best estimate.This mdr represents the ventralight st using echo ps 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 recurrent umbilical hernia thereby underwent laparoscopic repair with implant of ventralex st mesh (device 1).Per operative notes, ¿in the midline, the umbilical hernia containing hernia sac was resected and fascial defect was closed, ventralex st mesh (device 1) was placed over the fascia incorporating the mesh, adhesions were removed and fascia was sutured and tacked with sorbafix tackers.¿ (b)(6) 2013 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of ventralight st using echo ps mesh (device 2).Per operative notes, ¿the prior umbilical mesh (device 1) was noted slightly protrude into the hernia causing recurrence.The hernia sac was reduced and to the hernia defect, a ventralight st using echo ps mesh (device 2) was placed to cover the recurrent hernia.The fascia was closed, sutured and tacked circumferentially.¿ (b)(6) 2017 - patient was diagnosed with wound dehiscence and diaphragmatic defect thereby underwent laparoscopic repair with implant of biological mesh.Per operative notes, ¿adhesions between omentum and prior hernia mesh (device 1 and 2) were taken down.A sizeable defect in the diaphragm was reduced and reapproximated with sutures.A biological mesh was placed over the defect and secured 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: 24504904
• Report Number: 1213643-2026-00283
• Device Sequence Number: 10415926
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755(17)150628(10)HUXF1046
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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: 06/28/2015
• Device Catalogue Number: 5955680
• Device Lot Number: HUXF1046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2013
• 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: 48 YR
• Patient Sex: Male