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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX X2 RELEASE PADDLE WLKR-ADULT 9153641704; WALKER, MECHANICAL
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INVAMEX X2 RELEASE PADDLE WLKR-ADULT 9153641704; WALKER, MECHANICAL Back to Search Results
Model Number G6291-1
Device Problem Collapse (1099)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2010
Event Type  malfunction  
Manufacturer Narrative
Mdr is being submitted as a result of a retrospective complaint review.The product was returned for evaluation, and subsequent testing verified the complaint.The underlying cause was identified as a broken snap button causing the leg to collapse.
 
Event Description
The left rear leg of the walker allegedly collapsed.No serious injury is alleged.
 
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Brand Name
X2 RELEASE PADDLE WLKR-ADULT 9153641704
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
INVAMEX
parque industrial manimex
reynosa 88780
MX  88780
Manufacturer (Section G)
INVAMEX
parque industrial manimex
reynosa 88780
MX   88780
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5744417
MDR Text Key48031567
Report Number9616091-2016-00924
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 user facility
Reporter Occupation Other Caregivers
Remedial Action Replace
Type of Report Initial
Report Date 06/01/2010
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 NumberG6291-1
Device Lot Number91209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2010
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/01/2010
Initial Date FDA Received06/23/2016
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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