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

Catalog Number	0115810
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); Seroma (2069); Discomfort (2330)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of modified kugel patch, the patient experienced pain, discomfort and further it was found that the mesh was bent, and fluid was accumulating in the area of pain.Based on the information provided, no conclusions can be made as to the degree to which the device may have caused or contributed to the postoperative course.Seroma is a known inherent risk of surgery and listed in the adverse reactions section of the instructions-for-use supplied with the device as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of implant ((b)(6) 2016) is considered to be a best estimate based on the information provided.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, during an inguinal hernia repair in 2016, the patient was implanted with a modified kugel patch.In 2021, the patient experienced discomfort and pain.It was reported that when the patient was investigated for a different condition, it was found that the mesh was bent, and fluid was accumulating in the area of the pain.As reported, ¿it is not unbearable pain, but it is a hindrance to daily life.¿.

• Brand Name: MODIFIED KUGEL PATCH
• 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: 20506374
• Report Number: 1213643-2024-00507
• Device Sequence Number: 8400999
• Product Code: FTL
• UDI-Device Identifier: 00801741030796
• UDI-Public: (01)00801741030796
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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: 0115810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/22/2024
• 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: Required Intervention
• Patient Sex: Male