MAUDE Adverse Event Report: GOODBABY TREX2/WD86/ADULT/28/BH16/1255/U2222C/COM/U550 9153637774; WHEELCHAIR, MECHANICAL

Model Number TREX28R

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer alleges that the wheels are floppy.No other information provided.

• Brand Name: TREX2/WD86/ADULT/28/BH16/1255/U2222C/COM/U550 9153637774
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): GOODBABY; CH
• MDR Report Key: 4395299
• MDR Text Key: 17293329
• Report Number: 1531186-2015-00088
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/06/2015,12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TREX28R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2015
• Distributor Facility Aware Date: 12/16/2014
• Device Age: 57 MO
• Date Report to Manufacturer: 01/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other