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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. KUGEL PATCH SURGICAL MESH Back to Search Results
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.

 
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Brand NameKUGEL PATCH
Type of DeviceSURGICAL 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 Key8651482
MDR Text Key146652513
Report Number1213643-2019-04414
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK963141
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial
Report Date 05/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0010101
Device LOT NumberHUBZ0987
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/29/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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