MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH; SURGICAL MESH

Catalog Number	0112660
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fatigue (1849); Anxiety (2328)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As per ansm n° r2616339: date of occurrence: (b)(6) 2025 description of the incident: median hernia repair: single retro-muscular preperitoneal prosthesis (bard flat mesh) for a median peri- and supra-umbilical hernia, 5 cm in diameter.(b)(6) 2021: total hysterectomy, omentectomy, pelvic and lumbo-aortic drainage via laparotomy.Result: mesonephric-like ovarian adenocarcinoma.(b)(6) 2021: consultation findings: mesonephric-like ovarian carcinoma with invasion of the sigmoid colon.Approval of adjuvant chemotherapy with carboplatin-taxol.Patient's current condition: abdominal pain, fatigue, stress, exhaustion.Actions taken at the healthcare facility to manage the patient: not reported (nr).
Additional Manufacturer Narrative
The information provided is limited.A definitive implant date was not provided however it appears the patient was implanted in 2025 with the flat mesh to repair a small median peri- and supra-umbilical hernia.Post implant it is reported that the patient has experienced abdominal pain, fatigue, stress, and exhaustion.The information provided indicates that, in 2021, prior to the flat mesh implant, the patient underwent a total hysterectomy, omentectomy, pelvic and lumbo-aortic drainage via laparotomy, and was later diagnosed with mesonephric-like ovarian adenocarcinoma.Based on the information available, no conclusions can be made as to the degree to which the implant may be causing or contributing to the patient's postoperative symptoms.The adverse reaction section of the instructions-for-use, supplied with the device, identifies pain as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not pos 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 FLAT MESH
• 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: 25473325
• Report Number: 1213643-2026-00740
• Device Sequence Number: 10426243
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: 0112660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female