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

Catalog Number	5954610
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	06/15/2022
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 date of event (15-jun-2022) is considered to be the best estimate.This mdr represents the ventralight st mesh (device 2).Additional supplemental emdr was submitted to represent the composix e/x 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) 2005 - patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with implant of composix e/x mesh (device 1).Per operative notes, ¿the hernia defect in the midline was identified and omental adhesions were taken down.A piece of composix e/x mesh (device 1) was placed over the defect and secured with sutures.The fascia was closed and secured with sutures.¿ on (b)(6) 2021 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with removal of prior mesh and implant of ventralight st mesh (device 2).Per operative notes, ¿in the intra-abdominal cavity, at the cephalad portion of the incision, recurrent ventral hernia with prior mesh was noted.Adhesions of anterior abdominal wall and small bowel was lysed.The prior mesh (device 1) was removed and ventralight st mesh (device 2) was placed over the recurrent defect in intraperitoneal space and secured inplaced with sutures circumferentially.¿ ni- ni - 2022 ¿ patient had small bowel blockage thereby underwent repair.

• 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 ; 8005566756
• MDR Report Key: 24616073
• Report Number: 1213643-2026-00337
• Device Sequence Number: 9585683
• Product Code: FTL
• UDI-Device Identifier: 00801741031649
• UDI-Public: (01)00801741031649(10)NI
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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: 5954610
• 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: 03/17/2026
• 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: 70 YR
• Patient Sex: Female