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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE CANADA KIRKLAND TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL
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INVACARE CANADA KIRKLAND TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number MYON
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The product was returned on 06/03/2014.The product was returned to invacare (b)(4).However, no evaluation was available for review at the time of this investigation.Mdr is being submitted as a result of a retrospective complaint review.
 
Event Description
Per end-user, he was turning and his wheel just bent.
 
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Brand Name
TRANSPORT 20 IN X 16 IN 9153637574
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVACARE CANADA KIRKLAND
16769 hymus blvd.
kirkland qc H9H 3 L4
CA  H9H 3L4
Manufacturer (Section G)
INVACARE CANADA KIRKLAND
16769 hymus blvd.
kirkland qc H9H 3 L4
CA   H9H 3L4
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5747575
MDR Text Key48160902
Report Number3002416487-2016-00054
Device Sequence Number1
Product Code IOR
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 05/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMYON
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/05/2014
Initial Date FDA Received06/24/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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