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

Catalog Number	0117013
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient experienced unbearable parietal pain, chronic fatigue and memory loss and pain in both legs post implant of bard soft pre-shaped mesh.Reportedly, the patient was treated with pain medication, however it is reported that the medication was ineffective and patient subsequently underwent removal of the mesh.No additional information can be requested.Based on the information available, 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.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 n° r2609569: as reported, the patient was implanted with bard soft pre-shaped mesh on (b)(6) 2020.The patient underwent removal of the mesh on (b)(6) 2021.Date of occurrence: on (b)(6) 2020.Description of the incident: "unbearable parietal pain.Chronic fatigue.Memory loss.Pain in both legs.Painkillers ineffective." patient¿s current condition: loss of independence.Intractable pain making any social life impossible.Actions taken at the healthcare facility to manage the patient: n/a.

• Brand Name: BARD SOFT 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: 24876198
• Report Number: 1213643-2026-00514
• Device Sequence Number: 18611479
• Product Code: FTL
• UDI-Device Identifier: 00801741030901
• UDI-Public: (01)00801741030901(17)240928(10)HUDX1053
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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 Expiration Date: 09/28/2024
• Device Catalogue Number: 0117013
• Device Lot Number: HUDX1053
• 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: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2019
• 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: Required Intervention
• Patient Sex: Unknown