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

Catalog Number	5950007
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/28/2016
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-may-2015) is considered to be a best estimate.This emdr represents the bard/davol ventralex st mesh (device 3).An additional emdr was submitted to represent the bard/davol ventralex st mesh (device 2) and supplemental emdr was submitted to represent ventralex st mesh (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 provided: on (b)(6) 2015 - patient was diagnosed with left lower quadrant hernia thereby underwent open repair with implant of ventralex st mesh (device 2).Per operative notes, ¿an incision was made into the lower abdomen.The hernia sac was dissected out.A ventralex st mesh (device 2) was placed into the defect and secure it with sutures.¿ on (b)(6) 2015 - patient was diagnosed with recurrent left incisional hernia thereby underwent laparoscopic repair with implant of synthetic mesh.On (b)(6) 2016 - patient was diagnosed with recurrent abdominal wall hernia, pain thereby underwent open repair with implant of ventralex st mesh (device 3) and explant of synthetic mesh and ventralex st mesh (device 2).Per operative notes, ¿a transverse incision was made through the previously marked area.The hernia sac was dissected out.Previously placed synthetic mesh and ventralex st mesh (device 2) was removed entirely.A ventralex st mesh (device 3) was placed into the preperitoneal space and secure it with sutures.¿ on (b)(6) 2016 - patient was diagnosed with pain thereby underwent open repair with explant of ventralex st mesh (device 3) and primary closer of abdominal wall.Per operative notes, ¿a small incision was made into the left upper quadrant just above the umbilicus through previous incision.There was no hernia sac present.Previously placed ventralex st mesh (device 3) was removed.The defect was closed primarily.¿ as per previous legal claim, attorney alleges that patient underwent implant of ventralex st mesh (device 1) on (b)(6) 2007.(note: there was no information/ op notes provided regarding the ventralex st mesh (device 1) which was implanted on (b)(6) 2007 in medical records).

• 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: 23897317
• Report Number: 1213643-2025-01278
• Device Sequence Number: 19971484
• Product Code: FTL
• UDI-Device Identifier: 00801741031472
• UDI-Public: (01)00801741031472(17)170528(10)HUZE0877
• 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): 12/23/2025

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: 05/28/2017
• Device Catalogue Number: 5950007
• Device Lot Number: HUZE0877
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2015
• 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
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 71 KG