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

Catalog Number	0117015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Anxiety (2328); Sleep Dysfunction (2517); Ambulation or Postural Difficulties (2544)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As per ansm no (b)(4): as reported, on (b)(6) 2024 the patient underwent inguinal hernia repair with the implant of bard soft pre-shaped mesh.Type of surgery: inguinal.Date of surgery: (b)(6) 2024.Regarding side effects: postoperative pain: yes, pain still present: yes; reoperated on (b)(6) 2026, severity of pain: 8.Frequency of pain: periodic.Medications prescribed for pain: yes.Pain management center: yes.Patient's current condition: emotional distress: anxiety, stress, loss of quality of life.Physical impairment: persistent pain, loss of mobility.Fatigue, sleep disturbances.Occupational impairment: even though i am retired from farming, i am unable to help my wife with her work.Measures taken at the healthcare facility for the patient's care: n/a.
Additional Manufacturer Narrative
As reported, post implant of bard soft pre-shaped mesh the patient experienced persistent pain, loss of mobility.Fatigue, sleep disturbances, anxiety, and stress.It was further reported that the patient required medication and underwent a reoperation.Contact information was not provided.Furthermore, due to european privacy regulations, additional patient and case information could not be requested.As a result, the investigation is limited to the information currently available.Based on the information provided, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's alleged postoperative complications.The adverse reactions section of the instructions-for-use supplied with the device lists pain as a possible complication.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 (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.

• 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 ; +1(800)556-6756
• MDR Report Key: 50917202
• Report Number: 1213643-2026-01241
• Device Sequence Number: 17593511
• Product Code: FTL
• UDI-Device Identifier: 00801741030925
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 0117015
• Device Lot Number: HUHX0310
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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 Age: 64 YR
• Patient Sex: Male