Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHUNT KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SHUNT KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number DYNJ905860
Device Problems Material Fragmentation (1261); Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2019
Event Type  malfunction  
Event Description
Package and dual cover punctured, debris in sterile field.Medline.Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SHUNT KIT
Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
MDR Report Key8523266
MDR Text Key142476923
Report NumberMW5085950
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date07/31/2020
Device Catalogue NumberDYNJ905860
Device Lot Number18KBR618
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-