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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET HTR5500 HTR-DELUXE MODEL 5500 9153635378; CHAIR AND TABLE, MEDICAL

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INVACARE TAYLOR STREET HTR5500 HTR-DELUXE MODEL 5500 9153635378; CHAIR AND TABLE, MEDICAL Back to Search Results
Model Number HTR5500_PTO_35378
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Right front wheel broken.
 
Manufacturer Narrative
Follow up to be sent if additional information is received.
 
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Brand Name
HTR5500 HTR-DELUXE MODEL 5500 9153635378
Type of Device
CHAIR AND TABLE, MEDICAL
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
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key4913113
MDR Text Key6054964
Report Number1525712-2015-03851
Device Sequence Number1
Product Code KMN
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
Type of Report Initial
Report Date 06/18/2015
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 NumberHTR5500_PTO_35378
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/18/2015
Initial Date FDA Received07/14/2015
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;
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