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

Catalog Number	5950008
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hernia (2240)
Date of Event	12/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2016- patient was diagnosed with multiple ventral hernia thereby underwent open repair with implant of ventralex st mesh (device 1) and ventrio st mesh (device 2).Per op notes, "an upper midline incision was made.The epigastric ventral hernia was identified.An additional fascial defect caudal to this site was appreciated for defect.The incision was then extended distally in the midline and the hernia sac was identified.The small fascial bridge between the two defects were connected to create one large defect.A ventralex st mesh (device 1) was placed in the intraperitoneal position.An additional defect was identified in the supraumbilical position.A separate incision was made at the site.The incarcerated fat identified of the hernia sac and amputated at the level of the abdominal wall fascia.The defect was repaired with the ventrio st mesh (device 2) and secured with sutures." on (b)(6) 2016- patient was diagnosed with abdominal pain and eventrated ventral hernia mesh thereby underwent open repair with excision of ventralex st mesh (device 1) and ventrio st mesh (device 2) and implant of ventrio st mesh (device 3).Per op notes, ¿an upper midline incision was made over the previous incision line.An eventrated mesh was identified and removed.A ventrio st mesh (device 3) was placed and secured with sutures.The fascia was then closed with suture.".
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-jul-2016) is considered to be a best estimate.This emdr represents the ventralex st mesh (device 1).An additional supplemental emdr was submitted to represent the ventrio st (device 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: 25425395
• Report Number: 1213643-2026-00724
• Device Sequence Number: 13255858
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)180828(10)HUAU0925
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: 08/28/2018
• Device Catalogue Number: 5950008
• Device Lot Number: HUAU0925
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2016
• 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: 35 YR
• Patient Sex: Male