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	Discomfort (2330); Implant Pain (4561)
Date of Event	12/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient had experienced increased tingling pain at the scar site and persistent discomfort post implant of bard pre-shaped mesh.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.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 (b)(4): date of occurrence: (b)(6) 2025.As reported, on (b)(6) 2025 the patient underwent right inguinal hernia repair with the implant of bard pre-shaped mesh.Description of the incident: "increasing pain at the scar site, which is still hardened, noticed during the pharmacist¿s daily activities standing still, resuming walking after sitting down, sensation of warmth.Despite a busy work schedule, i cannot shake off the pain." reason for admission: right inguinal hernia.Summary of stay: conclusion of procedures and examinations: repair using a prosthetic mesh performed under good conditions and without complications.Patient¿s clinical condition on discharge: the patient¿s clinical condition is satisfactory and permits medical discharge today.As per the report of ultrasound of the right inguinal region dated (b)(6) 2026: reason for the examination: follow-up of a scar following surgery in september 2025 for a right inguinal hernia, with persistent discomfort and tingling pain at the scar site.No bowel dysfunction or fever.Conclusion: no abnormalities detectable on ultrasound of the right inguinal scar area.If painful symptoms persist, a further ct scan could be performed.Actions taken at the healthcare facility for the patient¿s management: n/a.

• 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: 24839919
• Report Number: 1213643-2026-00474
• Device Sequence Number: 18530842
• Product Code: FTL
• UDI-Device Identifier: 00801741016554
• UDI-Public: (01)00801741016554(17)291028(10)HUJY0432
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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: 0112710
• Device Lot Number: HUJY0432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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