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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX HEAVY DUTY ADULT WALKER 9153634971; WALKER, MECHANICAL

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INVAMEX HEAVY DUTY ADULT WALKER 9153634971; WALKER, MECHANICAL Back to Search Results
Model Number 6291-HDA
Device Problem Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The end user's wife states the arms of the walker are bowing outward.The wife gave a lot number that couldn't be referenced.
 
Manufacturer Narrative
Follow up to be sent if additional information is received.
 
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Brand Name
HEAVY DUTY ADULT WALKER 9153634971
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
INVAMEX
parque industrial manimex
reynosa 8878 0
MX  88780
Manufacturer (Section G)
INVAMEX
parque industrial manimex
reynosa 8878 0
MX   88780
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key4892090
MDR Text Key6832630
Report Number9616091-2015-01738
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 Patient Family Member or Friend
Type of Report Initial
Report Date 06/09/2015
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 Number6291-HDA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/09/2015
Initial Date FDA Received07/06/2015
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
Patient Outcome(s) Other;
Patient Weight175
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