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); Unspecified Infection (1930); Hernia (2240)
Date of Event	08/12/2019
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-nov-2018) is considered to be a best estimate.This emdr was submitted to represent the bard/davol ventralex st (device # 2).An additional supplemental emdr submitted to represent the bard/davol composix mesh e/x (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) 2013 ¿ patient was diagnosed with umbilical and incisional hernia thereby underwent laparoscopic repair with implant of composix e/x (device #1).Per operative notes, ¿a small incisional hernia and umbilical hernia close to one other were noted and composix e/x mesh (device #1) was placed in the abdominal cavity and tacked.The defect in the umbilicus was closed with sutures.¿ on (b)(6) 2019 - patient was diagnosed with recurrent ventral abdominal incisional hernia and pain thereby underwent open repair with partial removal of composix e/x mesh (device #1) and implant of ventralex st mesh (device #2).Per operative notes, ¿the hernia sac was opened which had a previous hernia mesh (device #1) and omentum within hernia sac.The mesh (device #1) was excised partially and ventralex st mesh (device #2) was placed into the defect and sutured.¿ on (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia, infection and pain thereby underwent open repair with removal of all meshes (device #1 and #2).Per operative notes, ¿adequate scar tissue and turbid fluid collection were identified.Both meshes (device #1 and #2) with sutures were identified and explanted.The recurrent defect was primarily closed with sutures.¿.

• 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: 22554516
• Report Number: 1213643-2025-00655
• Device Sequence Number: 9647521
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)201128(10)HUCY0482
• 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: 2019
• 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): 07/10/2025

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: 11/28/2020
• Device Catalogue Number: 5950008
• Device Lot Number: HUCY0482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2018
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 88 KG