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

Catalog Number	5950008
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	08/04/2016
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-apr-2015) is considered to be a best estimate.This mdr represents the ventralex st (device 2).An additional emdr was submitted to represent the ventralex 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.
Event or Problem Description
Per information received, on (b)(6) 2016- patient was diagnosed with incisional hernia thereby underwent open repair with implant of ventralex st meshes (device 1 and 2).Per op notes, ¿the hernia sac was identified in the abdominal region and was dissected.A medium ventralex st mesh (device 1) was placed throught the superior hernia defect and sutured.A large ventralex st mesh (device 2) was then placed through the inferior hernia defect so it sat flat against the abdominal wall on peritoneal surface.There was an overlap of this mesh (device 2) and the superior mesh (device 1) and was sutured¿.On (b)(6) 2016- patient was diagnosed with adhesions, thereby underwent laparoscopic repair.Per op notes, ¿the intra-abdominal contents were adherent to the mesh in the upper abdomen.The omentum was adherent to the peritoneal side of the mesh in upper abdomen.The adhesions were lysed.The mesh (device 1 and 2) were found pulled away from abdominal wall from retraction.The border of the meshes had peeled away from abdominal wall which is resutured¿.

• 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: 24745156
• Report Number: 1213643-2026-00409
• Device Sequence Number: 8779960
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)170428(10)HUZD1354
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: 04/28/2017
• Device Catalogue Number: 5950008
• Device Lot Number: HUZD1354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2015
• 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; Disability
• Patient Age: 52 YR
• Patient Sex: Female