MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX; SURGICAL MESH

Catalog Number	0115321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fatigue (1849); Heartburn/Indigestion (1883); Discomfort (2330); Ambulation or Postural Difficulties (2544); Unspecified Gastrointestinal Problem (4491)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient experienced complications post implant of the 3dmax mesh.Based on the information reported, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient¿s postoperative course.No additional information can be gathered as contact information was not provided and cannot be obtained.A review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.This mdr represents the 3dmax mesh right (device 2).An additional mdr was submitted to represent the 3dmax mesh left (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
As per ansm report ((b)(4)): description of the incident: "since these implants were fitted, and despite numerous reports to my gp and the surgeon who fitted the implants (3dmax mesh left- device1 / 3dmax right- device 2), i have been suffering from numerous adverse effects abdominal and pelvic pain during sexual intercourse during ejaculation, sometimes incapacitating.Permanent digestive problems significant pain with acute attacks every morning.Pain during exertion, walking, driving, sitting or bending (tying shoelaces).Significant and painful bloating.Severe aerophagia.Severe fatigue insomnia irritability development of food intolerances, such as dairy products.Halitosis despite good dental hygiene and regular check-ups.Feeling of a hard foreign body (like a pebble).Current condition of patient: nr.Actions taken by the healthcare facility to treat the patient: nr.

• Brand Name: 3DMAX
• 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: 24247698
• Report Number: 1213643-2026-00073
• Device Sequence Number: 9970749
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765(17)280628(10)HUHU0566
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081010
• 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): 01/20/2026

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: 0115321
• Device Lot Number: HUHU0566
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2023
• 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 Sex: Male
• Patient Weight: 72 KG