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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX T4/WD08/HD/ADULT/28/BH16/AT903/U2222C/U67 9153653566 WHEELCHAIR, MECHANICAL

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INVAMEX T4/WD08/HD/ADULT/28/BH16/AT903/U2222C/U67 9153653566 WHEELCHAIR, MECHANICAL Back to Search Results
Model Number T420RDAP
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

Provider reported brake bushing are falling out, clothing guards broken, back upholstery is stretched out and the seat is ripped.

 
Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

 
Manufacturer Narrative

The device was evaluated by the returns department which found that the seat is sagging to the point of rubbing on the cross brace. Chair in very used condition.

 
Event Description

Provider reported brake bushing are falling out, clothing guards broken, back upholstery is stretched out and the seat is ripped.

 
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Brand NameT4/WD08/HD/ADULT/28/BH16/AT903/U2222C/U67 9153653566
Type of DeviceWHEELCHAIR, 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 Key4873372
MDR Text Key6259550
Report Number9616091-2015-01630
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 Distributor,DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 06/29/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberT420RDAP
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/29/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2015
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 TREATMENT DATA
Date Received: 06/27/2015 Patient Sequence Number: 1
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