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

Catalog Number	0113710
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Depression (2361); Ambulation or Postural Difficulties (2544); Sexual Dysfunction (4510)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per ansm report (no (b)(4)): as reported a male patient born in 1974 was implanted with a bard mesh pre-shaped w/ keyhole on (b)(6) 2022.Date of occurrence: (b)(6) 2022 description of incident: male born in 1974 - 73 kg."when i woke up after the operation to insert a right inguinal prosthesis, i was unable to get up because the pain was too intense.I have been in a great deal of pain ever since.After several check-ups, it has been impossible to determine a medical reason for my suffering.Current condition of the patient: to date, the pain is still present, day and night, with stabbing pains in the lower abdomen and groin area.Severe and debilitating pain.I have great difficulty walking and no longer participate in sports or leisure activities.I can no longer work and have been dismissed by occupational health, despite numerous medications, the effects of which remain ineffective.Today, i have given up and hit rock bottom.I have been undergoing treatment since 2023 with a psychologist and psychiatrist (csm) following severe depression and numerous treatments.I also report pain in my genitals, making sexual intercourse very painful.I have not been able to live since that day on (b)(6) 2022.It is hellish." actions taken in the healthcare facility for the patient's care: (b)(6).
Additional Manufacturer Narrative
As reported, patient experienced chronic abdomen and groin pain, difficulty walking, severe depression, pain in genitals post implant of the bard mesh pre-shaped.Patient underwent treatments and medications to manage the symptoms post implant of mesh.To date the patient's doctors have not determined a medical reason for the patient's symptoms.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.

• 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: 24413360
• Report Number: 1213643-2026-00202
• Device Sequence Number: 10569313
• Product Code: FTL
• UDI-Device Identifier: 00801741030703
• UDI-Public: (01)00801741030703(17)260528(10)HUFT0644
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: PREAMENDMENT
• 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): 02/05/2026

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: 05/28/2026
• Device Catalogue Number: 0113710
• Device Lot Number: HUFT0644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2021
• 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: 73 KG