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

Catalog Number	5950009
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2017 - patient was diagnosed with multiple incarcerated incisional hernias thereby underwent laparoscopic repair with implant of ventralex st (device 1, 2 and 3) and synthetic mesh.Per op notes, ¿on the luq, adhesions of abdominal wall from omentum and small bowel were taken down.The prior mesh was noted pulled from the fascia and folded up was excised.On the ruq, three incisional hernia defects were noted and dissected free.Three ventralex st (device 1,2 and 3) were placed and sutured.On the llq, a large defect was identified, and a large synthetic mesh was placed and tacked.¿ (note: the prior mesh excised in this procedure was unknown) (b)(6) 2022 - patient was diagnosed with recurrent multiple ventral incisional hernias and bilateral inguinal hernias thereby underwent robotic assisted repair with excision of ventralex st (device 1,2 and 3), synthetic mesh and implant of bard soft mesh (device 4 and 5).Per op notes, ¿the midline hernias were identified with incarcerated omentum and bowel above the umbilicus.The incarcerated contents were reduced.Additional hernias were identified in llq and identified the bilateral inguinal hernias.Adhesions were lysed.All the meshes (device 1,2 and 3) and synthetic mesh from previous repair were excised.Scar was excised.On right rectus fascia, incision was made midline from the epigastric region to pubis and dissected the hernia defects.Myocutaneous flaps were raised.A large bard soft mesh (device 4) was placed and sutured.On left rectus fascia, incision was made midline from the epigastric region to pubis and dissected the hernia defects.Myocutaneous flaps were raised.A bard soft mesh (device 5) was placed and sutured¿.
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-feb-2017) is considered to be a best estimate.This emdr represents the bard/davol ventralex st (device 3).Additional supplemental emdr and an emdr were submitted to represent the bard/davol ventralex st (device 1 and 2).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: VENTRALEX ST
• 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: 24018842
• Report Number: 1213643-2026-00016
• Device Sequence Number: 10550097
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496(17)190428(10)HUBP1737
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: 04/28/2019
• Device Catalogue Number: 5950009
• Device Lot Number: HUBP1737
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2017
• 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: 62 YR
• Patient Sex: Male