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

Catalog Number	0010101
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of bard/davol kugel patch, the patient developed hernia recurrence.Based on the information provided, no conclusion can be made.Recurrence of the hernia is known inherent risk of surgery/use of the device and is 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.This mdr represents the bard/davol kugel patch (device #2).An additional mdr was submitted to represent the bard/davol perfix plug (device #1).Note, the date of implant (b)(6) 2014) is provided as an estimate based on the information provided.Not returned - remains implanted.
Event or Problem Description
As reported, the patient underwent bilateral inguinal hernia repair in 2005 and was implanted with perfix plug (device #1).Reportedly, nine years post implant (2014), the patient developed a left recurrent direct hernia, and underwent repair with the implant of a kugel patch (device #2).As reported the patient developed a recurrence of the 2014 repair and on (b)(6) 2022, underwent repair and was implanted with another mesh.

• Brand Name: 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: 15938690
• Report Number: 1213643-2022-00777
• Device Sequence Number: 6403853
• Product Code: FTL
• UDI-Device Identifier: 00801741016332
• UDI-Public: (01)00801741016332
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2022

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: 0010101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown