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

Catalog Number	0112720
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Discomfort (2330); Weight Changes (2607)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent bilateral inguinal hernia repair with the implant of flat mesh (right and left) on (b)(6) 2019.As reported, about 6 months post op, the patient experienced erectile dysfunction and consulted with a urologist who reported it may be due to his enlarged prostate.As reported about 3 years post implant, the patient developed a hardened ridge like area in the right groin area with discomfort/tenderness when palpated.It was reported that during follow up visit on (b)(6) 2023, surgeon informed the patient that there was nothing wrong with the area of implant, no further intervention was required and to follow-up with the urologist regarding erectile dysfunction.It was reported that the patient has a urologist appointment in (b)(6) 2023.Contact reports the patient is not having any issues with the left sided repair.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, three years post implant of the flat mesh the patient developed a ¿hardened ridge like area in the right groin area¿ accompanied by right sided discomfort.Upon review the patient¿s surgeon found nothing wrong with the area of concern and has advised the patient to follow up with his urologist.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 495 units released for distribution in july 2019.Note, the date of event (b)(6) 2022) is considered to be a best estimate based on the information available.  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.H3 other text : not returned - remains implanted.

• 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: 16814037
• Report Number: 1213643-2023-00159
• Device Sequence Number: 12195807
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2023

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: 06/28/2024
• Device Catalogue Number: 0112720
• Device Lot Number: HUDS2322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2019
• 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 Age: 68 YR
• Patient Sex: Male