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	Abdominal Pain (1685)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2017 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with implant of ventralex st (device #1).Per op notes, ¿the hernia sac was identified with peritoneal fat and dissected free.The sac and fat were reduced.A ventralex st (device #1) was placed and sutured.¿ (b)(6) 2018 - patient was diagnosed with recurrent ventral incisional hernia with abdominal pain thereby underwent open repair with implant of ventralex st (device #2).Per op notes, ¿the hernia sac identified, dissected free and opened.The hernia sac was excised.The previous mesh (device #1) appeared to be rolled up to the top of hernia recurrence.The old mesh was sutured back.A ventralex st (device #2) was placed and sutured.¿ (b)(6) 2018 ¿ patient had abdominal pain thereby provided with medications.(b)(6) 2019 ¿ patient had abdominal pain thereby underwent ct.(b)(6) 2019 ¿ patient had abdominal pain provided with medications.
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-oct-2017) is considered to be a best estimate.This emdr was submitted to represent the bard/davol ventralex st (device #2).Additional supplemental emdr represents the bard/davol 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.

• 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: 22724533
• Report Number: 1213643-2025-00726
• Device Sequence Number: 8288395
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)191128(10)HUBX1055
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2025

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: 11/28/2019
• Device Catalogue Number: 5950008
• Device Lot Number: HUBX1055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2017
• 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: 36 YR
• Patient Sex: Female