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

Catalog Number	5950009
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Cellulitis (1768); Unspecified Infection (1930)
Date of Event	04/30/2024
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-feb-2020) is considered to be a best estimate.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) 2021 ¿ patient was diagnosed with umbilical hernia thereby underwent open repair with the implant of ventralex st patch.Per operative notes, ¿an umbilical flap was raised separating the hernia sac from dermis.An underlay ventralex st patch was placed under the fascia and closed using sutures.¿ (b)(6) 2024 ¿ patient had umbilical cellulitis, intra-abdominal fluid collection thereby underwent ir drainage of abdominal fluid collection.(b)(6) 016 ¿ patient had pain and diagnosed with infected ventral hernia mesh thereby underwent open repair with the removal of mesh.Per operative notes, ¿the mesh in the abscess was not incorporated within fascia.The mesh was removed in its entirety along with abscess above the infected umbilical skin.The adhesions were separated out.¿.
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-feb-2020) is considered to be a best estimate.Addendum: this supplemental emdr is submitted to document additional information provided.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 additional information provided: (b)(6) 2021 ¿ patient was diagnosed with umbilical hernia thereby underwent open repair with the implant of ventralex st patch.Per operative notes, ¿an umbilical flap was raised separating the hernia sac from dermis.An underlay ventralex st patch was placed under the fascia and closed using sutures.¿ (b)(6) 2024 ¿ patient had umbilical cellulitis, intra-abdominal fluid collection thereby underwent ir drainage of abdominal fluid collection.(b)(6) 2024 ¿ patient had pain and diagnosed with infected ventral hernia mesh thereby underwent open repair with the removal of mesh.Per operative notes, ¿the mesh in the abscess was not incorporated within fascia.The mesh was removed in its entirety along with abscess above the infected umbilical skin.The adhesions were separated out.¿.

• 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: 22769705
• Report Number: 1213643-2025-00746
• Device Sequence Number: 9621355
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496(17)220228(10)HUEP1287
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 02/28/2022
• Device Catalogue Number: 5950009
• Device Lot Number: HUEP1287
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2020
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 94 KG