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

Catalog Number	5954450
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	08/12/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2009 ¿ patient was diagnosed with incarcerated incisional hernia thereby underwent open repair with implant of composix kugel mesh (device 1).Per operative notes, ¿ in the lower midline, above the umbilicus down to the symphysis pubis, the hernia sac was removed.The adhesions of small bowel within the sac was taken down.The defect was closed and composix kugel mesh (device 1) was placed over the defect and secured with sutures circumferentially.¿ on (b)(6) 2013 ¿ patient was diagnosed with recurrent abdominal wall ventral hernias (x2) thereby underwent open repair with implant of ventralight st mesh (device 2).Per operative notes, ¿ the recurrent hernia above and below the previously placed mesh (device 1) in midline was noted.The superior defect in suprapubic area and inferior defect in supraumbilical area was noted.In the superior portion of the umbilicus, hernia sac was encountered and dissected free down to the level of fascia.The superior edge of the prior mesh (device 1) had pulled away from the muscle.Omental adhesions to the fascia was taken down.Inferiorly small bowel and colon were adhered to prior mesh (device 1).Adhesions were taken down and round piece of ventralight st mesh (device 2) was placed into the abdominal cavity and secured inferiorly to prior mesh (device 1) with sutures.In the inferior defect, the mesh (device 1) pulled away slightly from pubic tubercle where the hernia recurred.The defect was reduced and defect was closed primarily with sutures.The wound was irrigated and secured and reapproximated with sutures circumferentially.¿ on (b)(6) 2013 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of ventrio st mesh (device 3).Per operative notes, the recurrent hernia at the superior aspect of the mesh (device 2) above the umbilicus was noted.The mesh (device 2) had torn apart from the fascia.The hernia sac was excised, the omentum and small bowel stuck and adherent to sac was released.A ventrio st mesh (device 3) was placed beneath the previously placed mesh (device 2) and secured circumferentially and reapproximated the old mesh (device 1 and 2) to the native fascia.The fascia was closed and secured with sutures circumferentially.¿.
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-apr-2012) is considered to be a best estimate.This mdr represents the ventralight st mesh (device 2).An additional supplemental emdr was submitted to represent the composix kugel 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.

• 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: 24543946
• Report Number: 1213643-2026-00298
• Device Sequence Number: 21176521
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618(17)140428(10)HUWD1072
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: 04/28/2014
• Device Catalogue Number: 5954450
• Device Lot Number: HUWD1072
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2012
• 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: 64 YR
• Patient Sex: Female