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

Catalog Number	0010303
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	09/24/2018
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-2008) is considered to be a best estimate.This emdr represents the ventralex mesh (device 2).Additional supplemental emdrs were submitted to represent the ventralex mesh (device 1) and ventralight st using echo ps mesh (device 3).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) 2008 - patient was diagnosed with ventral epigastric hernia and umbilical hernia thereby underwent open repair with the implant of ventralex meshes.Per op notes, "a supraumbilical hernia defect was present.The umbilical hernia was also noted.The umbilical defect was closed with a small ventralex patch (device 1) which was secured to the fascia using sutures.The larger supraumbilical defect was closed with a large ventralex mesh (device 2) which was placed in subfascial pocket using sutures." (b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh using echo ps (device 3).Per op notes, "there were significant adhesions of omentum up to the anterior abdominal wall and the previously placed mesh (device 1, 2) was taken down.Two small hernias were identified in the periumbilical area.An additional hernia was identified in the lower abdomen just to the left of the midline.A piece of ventralight st mesh using echo ps (device 3) was placed around the defect and secured around periphery using sorbafix tacks.".

• 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: 25390392
• Report Number: 1213643-2026-00712
• Device Sequence Number: 5191536
• Product Code: FTL
• UDI-Device Identifier: 00801741016486
• UDI-Public: (01)00801741016486(17)130628(10)HUSD1714
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K132441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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: 06/28/2013
• Device Catalogue Number: 0010303
• Device Lot Number: HUSD1714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2008
• 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: 44 YR
• Patient Sex: Female