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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER INTRODUCER, CATHETER

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TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2022
Event Type  malfunction  
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Brand NameGLIDESHEATH SLENDER
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
elkton MD 21921
Manufacturer (Section G)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
elkton MD 21921
Manufacturer Contact
stephanie handy
950 elkton blvd.
elkton, MD 21921
9499890491
MDR Report Key15050863
Report Number1118880-2022-00063
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173831
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number80-1055
Device Lot Number0000107379
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/28/2021
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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