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	Adhesion(s) (1695); Seroma (2069); Hernia (2240)
Date of Event	03/11/2016
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.This mdr represents the ventralight st using echo ps mesh (device 2).Additional supplemental emdr were submitted to represent the ventralight st (device 1) and ventralight st mesh (device 3).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 incisional hernia thereby underwent open repair with implant of ventralight st mesh (device 1).Per operative notes, ¿a ventral incisional hernia at the site of old trocar site was dissected down and excess sac was released.The adhesions of omentum were released, and peritoneum was closed with sutures.A ventralight st mesh (device 1) was placed over the defect and secured it to the fascial edges with sutures.¿ (b)(6) 2014 ¿ patient was diagnosed with recurrent ventral incisional hernia thereby underwent laparoscopic repair with implant of ventralight st using echo ps mesh (device 2) and ventralight st (device 3).Per operative notes, ¿a hernia defect in the midline leaning towards the left at the level above the umbilicus was noted.Scar tissues were excised and ventralight st using echo ps mesh (device 2) was placed into the position covering the entire defect and tacked in place.In the right side of the midline, that was not covered by the mesh (device 2), therefore another ventralight st mesh (device 3) was pulled into the position covering and overlapping the prior mesh (device 2) and entire fascial defect.The fascia was closed and secured with sutures and tacks." (b)(6) 2016 ¿ patient was diagnosed with recurrent ventral incisional hernia and chest wall abscess thereby underwent open repair with implant of synthetic mesh.Per operative notes, ¿the hernia sac was dissected out, and the fascia was freshened up around the edges, and a piece of synthetic mesh was placed over the defect secured with sutures.The abscess in the chest wall was incised and drained.¿ (b)(6) 2018 ¿ patient was diagnosed with recurrent ventral incisional hernia with seroma thereby underwent laparoscopic repair with ventralight st using echo ps mesh (device 4).Per operative notes, ¿extensive omental adhesions were taken down.The incarcerated omentum with necrosis was removed.The seroma in the abdominal wall from prior repair was aspirated and ventralight st using echo ps mesh (device 4) was placed over the hernia defect was placed over the hernia defect sutured and tacked.¿.

• 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: 24546091
• Report Number: 1213643-2026-00303
• Device Sequence Number: 9485804
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755(10)NI
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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 Catalogue Number: 5955680
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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