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

Catalog Number	0117008
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Dyspnea (1816); Pain (1994)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the patient was implanted with soft mesh "two weeks ago" (contact could not remember the exact date).Contact reports the patient "is having complications from the mesh - not able to breath on her own after surgery, in a lot of pain, on different kinds of medication.".
Additional Manufacturer Narrative
As alleged, post implant of soft mesh, patient experienced difficulty breathing after the surgery and pain.Reportedly, patient was treated with medications.Based on the information provided, no conclusions can be made as to the degree to which the implant may be causing or contributing the patient¿s postoperative symptoms.Post surgical pain is a clinically understood potential complication of surgery/use of the device and is identified in the instructions-for-use provided with the device, as a possible complication.A review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this lot of (b)(4) units.Note, the date of event (06-aug-2025) is considered to be a best estimate based on the date of awareness.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: 22850596
• Report Number: 1213643-2025-00769
• Device Sequence Number: 4419491
• Product Code: FTL
• UDI-Device Identifier: 00801741030857
• UDI-Public: (01)00801741030857(17)281128(10)HUHZ0980
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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 Catalogue Number: 0117008
• Device Lot Number: HUHZ0980
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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: Female