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

Catalog Number	0010218
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fatigue (1849); Hematoma (1884); Ambulation or Postural Difficulties (2544)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Per ansm user report (in summary) (b)(4): date of occurrence: (b)(6) 2024: period of occurrence: in the week following the operation.Description of incident: laparotomy with prostheses two prostheses were installed: a 12 cm symbotex prosthesis and a 20 cm x 25 cm ventrio bard prosthesis with non-absorbable staples.Since this operation, i have had intense pain in my stomach, from the lower abdomen to the tips that appear at the navel, subcutaneous, morphine since 2024 and followed up with 100 painkillers, and it's useless.Comments: they should have told me before the operation that it would hurt even more than before, and that my life would be ruined.I tried to see other surgeons and they told me that i would need another operation.So, what does the future hold for me at 48 years old?¿ procedure date: (b)(6) 2025.Title: drainage of a parietal haematoma lesions observed: patient three weeks after double hernia repair by laparotomy with intraperitoneal prostheses, initial recovery uneventful; during a violent lifting effort, formation of a large, hyperalgesic parietal hematoma.Current patient status: since the operation, i have been on morphine and am being monitored by a pain management center.I can no longer go on long walks, i can't sit for long periods of time, i can't bend over because the pain is so intense that it brings tears to my eyes.I can't bend down to play with my grandchildren, and if i walk for a short while, when i get home, i cry because i'm in so much pain.But i can't wear a belt because it hurts! and when i try to sleep, all night long, i toss and turn and it's as if someone is tearing my stomach apart.I can't lie on my back because it pulls down to my pubic bone, and i can't lie on my stomach because it's painful, so i don't get any sleep.So, i'm very tired.Actions taken in the healthcare facility for the patient's care: (b)(6).
Additional Manufacturer Narrative
Post ventrio mesh implant the patient alleges intense abdominal pain, mobility limitations, and fatigue and takes medications to manage the symptoms.As reported "during a violent lifting effort" a hematoma formed and the patient underwent drainage.Based on the information available to date, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative complications.The adverse reaction section of the instructions-for-use, supplied with the device identifies pain and hematoma as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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.

• 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: 24413799
• Report Number: 1213643-2026-00205
• Device Sequence Number: 10517779
• Product Code: FTL
• UDI-Device Identifier: 00801741016455
• UDI-Public: (01)00801741016455
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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 Catalogue Number: 0010218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 48 YR
• Patient Sex: Female