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

Catalog Number 0010101

Device Problems Use of Device Problem (1670); Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

As reported the user unintentionally damaged the mesh during insertion using a spatula.Photos were provided, and show where the spatula penetrated the mesh leaving a tear/hole in the mesh.Based on the event as reported the sample is not needed for root cause determination.This complaint is confirmed for tear/hole in the mesh being caused by the spatula being used to insert the mesh.Root cause is determined to be use related as the instructions-for-use instruct the user to insert the mesh using a finger not an instrument.Per the instructions-for-use, "with finger inside positioning slit of pocket, roll the patch around finger and insert into the previously crated pocket.The "memory recoil ring" enables simplified positioning." a review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in december 2017.Not returned.

Event Description

It was reported that on (b)(6) 2019 the surgeon attempted to insert the bard/davol kugel patch using a spatula.As reported the surgeon unintentionally damaged the mesh during insertion.The surgeon used another mesh to complete the case with no injury to the patent.

• Brand Name: KUGEL PATCH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 8651482
• MDR Text Key: 146652513
• Report Number: 1213643-2019-04414
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016332
• UDI-Public: (01)00801741016332
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2022
• Device Catalogue Number: 0010101
• Device Lot Number: HUBZ0987
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1