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

Catalog Number	5950008
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2016 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventrio st mesh (device 1).Per op notes, "an incision to the left abdominal scar, a ventrio st (device 1) was placed." (b)(6) 2017 - patient was diagnosed with recurrent incarcerated incisional hernia and abdominal wall seroma thereby underwent open repair with the implant of ventralex st mesh (device 2).Per op notes, "an incision to the prior scar, excised the seroma cavity.The fascia was identified around the hernia and underlying adhesions freed from fascia.A ventralex st mesh (device 2) was secured." (b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of bard soft mesh (device 3).Per op notes, "extensive adhesiolysis to dissect omental adhesions free from the abdominal wall.There was a large piece of mesh which had incorporated with the posterior sheath and could not be separated.A bard soft mesh (device 3) and a synthetic mesh were placed using sutures.".
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-nov-2016) is considered to be a best estimate.This mdr represents the ventralex st (device 2).An additional supplemental emdr was submitted to represent the ventrio st (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: 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: 24511121
• Report Number: 1213643-2026-00280
• Device Sequence Number: 18631897
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)181228(10)HUAY1428
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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: 12/28/2018
• Device Catalogue Number: 5950008
• Device Lot Number: HUAY1428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2016
• 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: 63 YR
• Patient Sex: Female