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 Code	Hernia (2240)
Date of Event	09/04/2019
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 manufacturing date (15-may-2014) 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 phasix st mesh (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.
Event or Problem Description
Per information provided: (b)(6) 2014 - patient was diagnosed with incisional and umbilical hernias thereby underwent open repair with the implant of ventralex st mesh (device 1).Per op notes, "a small umbilical hernia and large incisional hernia at lower midline abdomen was noted.The larger more inferior hernia was repaired with a medium ventralex st patch (device 1) was inserted into the peritoneal cavity with the smooth surface posteriorly and superior aspect of patch extended above the umbilical hernia repair using sutures." (b)(6) 2019 - patient was diagnosed with incisional ventral, and umbilical ventral hernia thereby underwent open repair with the removal of mesh (device 1) and implant of phasix st mesh (device 2).Per op notes, "the old mesh (device 1) was completely removed intact.There was a recurrent hernia lateral to the old mesh.Several hernias above the umbilical area were extended and connected.A phasix st mesh (device 2) was placed in an underlay fashion and secured circumferentially using sutures." (b)(6) 2021 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair.Per op notes, ¿a small periumbilical recurrent incisional hernia was noted.The fascial defect was closed using sutures." (note: the phasix st mesh was not seen during this procedure).

• 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: 25668603
• Report Number: 1213643-2026-00829
• Device Sequence Number: 5764711
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)160528(10)HUYE0324
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: 05/28/2016
• Device Catalogue Number: 5950008
• Device Lot Number: HUYE0324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2014
• 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: 45 YR
• Patient Sex: Female