MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD MESH PRE-SHAPED W/ KEYHOLE; SURGICAL MESH

Catalog Number	0112710
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Dysuria (2684); Constipation (3274); Neuralgia (4413); Hyperesthesia (4420)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As alleged, post implant of bard pre-shaped mesh the patient experienced chronic neuropathic pain, neuralgia, pain in the right testicle, nerve injuries, radiating pain in pubis and the scar area.For pain relief patient underwent pain management program and multiple medications along with pulsed radiofrequency therapy.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 complication.The adverse reaction section of the instructions-for-use, supplied with the device identifies pain as a possible complication.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) 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.
Event or Problem Description
As reported per ansm report (b)(4) in summary: description of the incident: following abdominal pain and swelling in the right groin, the patient underwent surgery on (b)(6) 2022 with the implantation of bard pre-shaped mesh, for a right indirect inguinal hernia using the lichtenstein technique.Clinical consequences and current status: "since undergoing this surgery in 2022, i have been suffering from chronic, debilitating neuropathic pain, including neuralgia, algodystrophy of the right big toe, and allodynia.Pain in the right testicle.Pain in the inner right thigh.Injuries to the ilioinguinal, iliohypogastric, and genitofemoral sensory nerves.Pain in the pubic region, pubis, scar area, and radiating toward the back.Since on (b)(6) 2023, i have been under the care of the pain management, where several treatments have been implemented by the multidisciplinary team, several sessions of qutenza patches in the outpatient department.Teens.About twenty ketamine infusions on an outpatient basis.Two sessions of pulsed radiofrequency therapy.I'm also on a fairly strong medication: 120 mg of cymbalta a day.300 mg of trileptal per day.2 versatis patches per night/day.13 drops of laroxyl per day.Occasionally oxycodone and oxynorm." as per follow up visits (18-may-2022 to 7-jan- 2025): as reported, the patient had multiple follow ups due to the post-operative complications including severe, sharp electric, nerve injury, neuropathic like pain in the right testicle, dysuria, difficulty in defecating, musculoskeletal pain, hypersensitivity.The patient was hospitalized due to postprandial pain in the epigastric region and right upper quadrant.The patient also having inability to perform major household tasks and significant difficulty sleeping.For the pain management the patient had taken multiple medications, joined pain management programs and also considering for the removal of the mesh implant.

• Brand Name: BARD MESH PRE-SHAPED W/ KEYHOLE
• 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: 24778577
• Report Number: 1213643-2026-00433
• Device Sequence Number: 12278296
• Product Code: FTL
• UDI-Device Identifier: 00801741016554
• UDI-Public: (01)00801741016554(17)260328(10)HUFR1204
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: 03/28/2026
• Device Catalogue Number: 0112710
• Device Lot Number: HUFR1204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2021
• 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: 65 KG