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

Catalog Number	0010214
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	04/11/2013
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-jan-2012) is considered to be a best estimate.This emdr represents the ventrio mesh (device 2).An additional supplemental emdr was submitted to represent the bard flat mesh (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) 2009 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with implant of bard flat mesh (device 1).Per op notes, "the hernia defect was identified and dissected free.The previous mesh was placed from prior repair was noted.The hernia sac was opened and the contents were reduced.A bard flat mesh (device 1) was placed and sutured." (note: the old mesh visualized in this procedure was unknown) on (b)(6) 2013 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of ventrio mesh (device 2).Per op notes, "lower midline incision was opened.The hernia sac was identified and the contents showed that there was small bowel herniating through the sac was reduced.The hernia sac was excised.The old mesh (device 1) was noted intact.A ventrio mesh (device 2) was placed as an underlay and tacked to the old mesh (device 1) using absorbable tacks." on (b)(6) 2013 - patient was diagnosed with abdominal wound infection thereby underwent repair with drainage of the foul-smelling fluid, debridement of necrotic tissues and packed with dressing.Multiple hernia repairs were performed last one on (b)(6) 2013 with mesh presents following several days of continued drainage.Wound drainage for last two weeks and instructed to pack with dressings.Since the staples were removed on (b)(6) 2013.

• Brand Name: VENTRIO MESH
• 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: 25666785
• Report Number: 1213643-2026-00825
• Device Sequence Number: 5764632
• Product Code: FTL
• UDI-Device Identifier: 00801741016417
• UDI-Public: (01)00801741016417(17)150128(10)HUWA1124
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: 01/28/2015
• Device Catalogue Number: 0010214
• Device Lot Number: HUWA1124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2012
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 108 KG