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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. ROLLATOR JR RED 9153641188; WALKER, MECHANICAL
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INVACARE REHABILITATION EQUIPMENT CO. ROLLATOR JR RED 9153641188; WALKER, MECHANICAL Back to Search Results
Model Number 65100-JR
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Mdr is being submitted as a result of a retrospective complaint review.Per the irs or return fields in oracle the evaluation is identified as a release mechanism / release handle damaged.Broken plastic on seat that wraps around right side frame.
 
Event Description
The dealer alleges, that the seat broke where it connects to the right side.There was no injury.
 
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Brand Name
ROLLATOR JR RED 9153641188
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
INVACARE REHABILITATION EQUIPMENT CO.
no.5 weixi road, sip
suzhou jiangsu 21512 1
CH  215121
Manufacturer (Section G)
INVACARE REHABILITATION EQUIPMENT CO.
no.5 weixi road, sip
suzhou jiangsu 21512 1
CH   215121
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5748881
MDR Text Key48211367
Report Number3008262382-2016-00496
Device Sequence Number1
Product Code ITJ
Combination Product (y/n)N
Reporter Country CodeUS
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 05/09/2014
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 Number65100-JR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/09/2014
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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