MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Bard Mesh Pre-Shaped; Surgical Mesh

Catalog Number	0113710
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fatigue (1849); Neuropathy (1983); Myalgia (2238); Hernia (2240); Discomfort (2330); Arthralgia (2355)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported in summary per ansm no (b)(4): reportedly, "my pain relating to the hernia prosthesis began in (b)(6) 2025.I underwent surgery (pre-shaped mesh implant) on (b)(6) 2020 following the detection of an inguinal hernia in 2019.Apart from sporadic pain that tended to go away, i did not have any major problems with this prosthesis for the first four years.In (b)(6) 2025, following a sudden awkward movement, i experienced severe pain in my groin.As this pain was very similar to that of an inguinal hernia, i assumed it would eventually go away.This was not the case, however, and the pain became chronic." 2026, patient reported joint and muscle pain, fatigue and weakness.Patient attended the ed where neuropathic pain was diagnosed, ct scan revealed no recurrent hernia.Multiple investigations including mri, abdominal and pelvic ct scan, blood tests and ultrasound, no diagnosis was identified to explain the hernia-related pain.Several specialists suggested the hernia prosthesis may be the cause.As of (b)(6) 2026, patient reported severe chronic hernia pain radiating through the pelvic region, thigh and abdomen, severe and constant muscle and joint pain affecting quality of life, and partial relief with laroxyl.Patient stated, "i am convinced that my hernia prosthesis is the cause of my problems," and was seeking evidence of immune rejection.Apart from a minor inguinal hernia, no precise diagnosis had been established.On (b)(6) 2026 - abdominal/pelvic ct scan for abdominal/right inguinal pain following right inguinal hernia repair in 2020.Results showed no recurrence of the right inguinal hernia, no inguinal collection or hematoma, and no abdominal or inguinal abnormalities to explain the symptoms.Anterior slippage of l5 with bilateral isthmic lysis was noted.(b)(6) 2026 - ed visit - patient reported one month of abdominal pain at the hernia repair site, worsening after moving house and carrying heavy loads.Clinical examination revealed right inguinal pain, bowel dysfunction, nausea or vomiting.Ct scan was normal.Gl surgery recommended inguinal ultrasound and pain management consultation for neuropathic pain.(b)(6) 2026 - patient reported approximately six months of worsening right groin pain."since his operation, he has described discomfort in the groin area with occasional pain.The onset of this intense pain appears to coincide with physical exertion experienced approximately six months ago." the pain was constant, worsened with physical exertion and radiated to the scrotum.Additional radiating pain extended from the buttock and root of the right thigh to the sole of the foot.Mri, ct scan, and ultrasound showed mild l5-s1 discopathy.Lamaline provided partial relief.(b)(6) 2026 - consult, clinically, no evidence of recurrence, confirmed by the ct scan of (b)(6) 2026.The pain does not have neuropathic characteristics and in my view, has a nociceptive and probably neuroplastic component due to the presence of numerous atypical radiations and a link to food intake it is responsible for a complete cessation of activities, accompanied by marked catastrophising.He also experiences sensations of temporal and spatial disorientation and diffuse radiating pain in the limbs during pain peaks.For my part, i therefore do not support a diagnosis of a nerve conflict or any other post-operative complication that might justify surgical treatment, even exploratory surgery, given the risk that it could be futile or debilitating.(b)(6) 2026 - ct scan small direct right inguinal hernia containing fatty tissue.No other abnormalities were observed.Anterior spondylolisthesis at l5-s1 with bilateral isthmic lysis was noted.
Additional Manufacturer Narrative
As reported, the patient experienced multiple postoperative complications following implantation of the pre-shaped mesh.The patient was evaluated by treating physicians and underwent diagnostic imaging; however, the cause of the reported symptoms has not been established.Contact information was not provided.Furthermore, due to european privacy regulations, additional patient and case information could not be obtained.As a result, the investigation is limited to the information currently available.Based on the information provided, no conclusions can be drawn regarding the degree to which the implanted mesh may have caused or contributed to the patient's postoperative complications.Hernia recurrence and pain are clinically understood potential complications of surgery/use of the device and are listed in the adverse reactions section of the instructions-for-use, supplied with the device, as possible complications.A review of manufacturing records was performed and found that the device was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 501 units released for distribution.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: Bard Mesh Pre-Shaped
• 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 ; +1(800)556-6756
• MDR Report Key: 50101363
• Report Number: 1213643-2026-00994
• Device Sequence Number: 15953470
• Product Code: FTL
• UDI-Device Identifier: 00801741030703
• UDI-Public: (01)00801741030703(17)240428(10)HUDR1596
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2026

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: 04/28/2024
• Device Catalogue Number: 0113710
• Device Lot Number: HUDR1596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2019
• 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: Other
• Patient Sex: Male
• Patient Weight: 158 LB