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

Catalog Number	0117010
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent laparoscopic hernia repair on (b)(6) 2020 and was implanted with a soft mesh with postoperative haemostasis, pain relief, and symptomatic management.As reported, there was suppuration of the incision and the patient underwent puncture to extract fluid and the incision was treated with anti-infective therapy.Reportedly, the incision healed on (b)(6) 2021.
Additional Manufacturer Narrative
As reported, the patient developed an infection post implant of the soft mesh.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 postoperative infection.Review of manufacturing records was performed and found the device was manufactured to specification.To date, this is the only reported complaint for this lot of (b)(4) units.The instructions-for-use, supplied with the device lists infection as a possible complication in the adverse reactions section.Additionally, the warnings section states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh".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
• 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: 22374208
• Report Number: 1213643-2025-00546
• Device Sequence Number: 14613561
• Product Code: FTL
• UDI-Device Identifier: 00801741030871
• UDI-Public: (01)00801741030871(17)240828(10)HUDW0875
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: 08/28/2024
• Device Catalogue Number: 0117010
• Device Lot Number: HUDW0875
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2019
• 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: Male