MAUDE Adverse Event Report: UNKNOWN ALUM TRANS 19 IN BLUE W/FTRST 9153640160; WHEELCHAIR, MECHANICAL

Model Number LTTB19FR

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Per email customer received the item, the bolts that hold the footrests on to the hanger were not included.The footrests were not assembled.

• Brand Name: ALUM TRANS 19 IN BLUE W/FTRST 9153640160
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4415073
• MDR Text Key: 5371543
• Report Number: 1531186-2015-00223
• 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: 01/12/2015,12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LTTB19FR
• 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: 01/12/2015
• Distributor Facility Aware Date: 12/29/2014
• Date Report to Manufacturer: 01/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other