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	Neuropathy (1983); Pain (1994); Swelling/ Edema (4577)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As alleged, post implant of the soft mesh pre-shaped w/ keyhole the patient experienced adverse symptoms including pain, neuropathy, and edema.Based on the information provided no conclusions can be made.The degree to which the implant used to treat the patient, may be causing, or contributing to the patient¿s postoperative course is unknown.Pain is listed as a possible complication in the adverse reaction section of the instructions-for-use, provided with the device.A review of the manufacturing records was performed and found the lot 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.
Event or Problem Description
As reported by ansm in summary: the patient underwent a complicated hysterectomy, with subsequent appearance of bilateral inguinal hernia.On (b)(6) 2024 the patient underwent repair of the hernia using the lichtenstein technique and placement of a soft mesh pre-shaped w/ keyhole.As reported the patient has been experiencing intense pain at the right scar site following surgery and presented to her doctor on (b)(6) 2024.Per doctors note , "she is still very painful, with pain linked to suprapubic edema and pain at the level of the right inguinal scar, with suspected granuloma or neuroma.She will have her complementary mri in early (b)(6).On examination today, it was difficult to localize the neuroma, as there was no specific area of pain.Inguinal region is very sensitive.While waiting for the mri, i suggest an ileofascial block for pain relief today.I hope this will relieve her for a few days.I'll see her again as soon as she's had her mri, and i'll be sure to keep you informed of what to do next." patient's current condition: "intense pain in the right scar diffuse neuropathic pain.Pain on the top of the legs and top of the feet floating sensation in the right groin electric shocks neuroma".

• 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 ; 8005566756
• MDR Report Key: 22853246
• Report Number: 1213643-2025-00773
• Device Sequence Number: 15567724
• Product Code: FTL
• UDI-Device Identifier: 00801741030925
• UDI-Public: (01)00801741030925(17)280628(10)HUHV0033
• 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
• 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: 0117015
• Device Lot Number: HUHV0033
• 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: 08/31/2023
• 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 Sex: Female
• Patient Weight: 61 KG