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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET MECHANICAL (MANUAL) WHEELCHAIR; 890.3850

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INVACARE TAYLOR STREET MECHANICAL (MANUAL) WHEELCHAIR; 890.3850 Back to Search Results
Model Number PROX4S
Device Problems Break (1069); Mechanical Problem (1384); Device Tipped Over (2589); Connection Problem (2900)
Patient Problem Injury (2348)
Event Date 09/10/2014
Event Type  malfunction  
Event Description
End user reported that the crossbrace on his prox4s wheelchair broke in half, dumping him from the chair.He states bumps and bruises to his right side and right elbow.The user was in his kitchen cooking and while doing so his crossbrace snapped in the middle where the two crossbraces connect damaging the right side.Medical intervention alleged.
 
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Brand Name
MECHANICAL (MANUAL) WHEELCHAIR
Type of Device
890.3850
Manufacturer (Section D)
INVACARE TAYLOR STREET
1200 taylor street
elyria OH 44036
Manufacturer (Section G)
INVACARE TAYLOR STREET
1200 taylor street
elyria OH 44036
Manufacturer Contact
karen loughren
one invacare way
elyria, OH 44035
8003336900
MDR Report Key4125306
MDR Text Key19086822
Report Number1525712-2014-06429
Device Sequence Number1
Product Code IOR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 09/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberPROX4S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/10/2014
Initial Date FDA Received09/29/2014
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 Age72
Patient Weight88
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