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

Catalog Number	0010302
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	12/03/2009
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-jul-2008) is considered to be a best estimate.This emdr represents the bard ventralex mesh (device 2).Additional supplemental emdrs were submitted to represent the bard ventralex mesh (device 1 & 4).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) 2008: patient was diagnosed with ventral hernia, umbilical hernia, thereby underwent open repair with implant of ventralex meshes (device 1 and 2).Per op notes, "the hernia sac was identified in umbilical region and was dissected.The fascia superior to this defect was noted and a fascial defect beneath the umbilicus was also noted.The umbilical hernia was repaired by placing a ventralex mesh (device 1) through the defect and sutured against the anterior abdominal wall.Then the superior fascial defect was repaired by placing ventralex mesh (device 2) and sutured against the anterior abdominal wall." on (b)(6) 2009: patient was diagnosed with recurrent ventral hernia, thereby underwent laparoscopic repair with implant of composix l/p mesh (device 3), ventralex mesh (device 4).Per op notes, "the previous meshes (device 1 and 2) was in overlap and the hernia found protruding through the meshes (device 1 and 2) with both bowel and omentum which was found adherent to the free edge of the mesh.Adhesiolysis were performed.The previous defect was not covered entirely and therefore a large composix l/p (device 3) was placed covering the previously placed meshes (device 1 and 2) and the fascia defect, tacked with sorbafix fixation device.A ventralex mesh (device 4) was placed in abdominal region and was tacked with sorbafix fixation device against the abdominal wall.".

• 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: 25026477
• Report Number: 1213643-2026-00572
• Device Sequence Number: 18435731
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479(17)130828(10)HUSG0821
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/24/2026

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: 08/28/2013
• Device Catalogue Number: 0010302
• Device Lot Number: HUSG0821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2008
• 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: 28 YR
• Patient Sex: Female