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

Catalog Number	5950008
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Fistula (1862)
Date of Event	12/27/2018
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 ventralex (device #2).An additional supplemental mdr was submitted to represent the composix kugel (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) 2011 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of the bard composix kugel mesh (device #1).Per operative notes, ¿a bard composix kugel mesh (device #1) was placed and sutured.¿ on (b)(6) 2015 - patient was diagnosed with recurrent ventral incisional hernia, adhesion, scar tissue thereby underwent open repair with implant of ventralex st mesh (device #2).Per operative notes, ¿adhesions were taken down.A ventralex st mesh (device #2) was placed and sutured.¿ on (b)(6) 2018 - patient was diagnosed with abdominal wall abscess thereby underwent repair with incision and drainage of abscess.On (b)(6) 2018 - patient was diagnosed with abscess, abdominal wound, fistula, adhesion thereby underwent open repair with explant of bard composix kugel mesh (device #1) and ventralex st mesh (device #2).Per operative notes, ¿adhesions, abdominal wound, abscesses were taken down.All prior meshes bard composix kugel mesh (device #1) and ventralex st mesh (device #2) were removed.¿.

• Brand Name: MESH - VENTRALEX
• 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: 22574170
• Report Number: 1213643-2025-00673
• Device Sequence Number: 18523826
• Product Code: FTL
• UDI-Device Identifier: 00801741031489
• UDI-Public: (01)00801741031489(17)170528(10)HUZD1543
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: 5950008
• Device Lot Number: HUZD1543
• 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: 07/23/2025
• 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
• Patient Age: 45 YR
• Patient Sex: Male