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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DOLOMITE AB ROLLATOR 9153651315; WALKER, MECHANICAL

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DOLOMITE AB ROLLATOR 9153651315; WALKER, MECHANICAL Back to Search Results
Model Number JAZZSTD
Device Problem Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Should additional information become available for the patient a supplemental record will be filed.
 
Event Description
Brakes popping up, will not lock.
 
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Brand Name
ROLLATOR 9153651315
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
DOLOMITE AB
vaxjovagen 303
dio
SW 
Manufacturer (Section G)
DOLOMITE AB
vaxjovagen 303
dio
SW  
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5500719
MDR Text Key40633769
Report Number9615290-2016-00052
Device Sequence Number1
Product Code ITJ
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 02/26/2016
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 NumberJAZZSTD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/26/2016
Initial Date FDA Received03/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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