MAUDE Adverse Event Report: UNKNOWN HVY DUTY TRANSPORT 22 IN-W/FTRST 9153643753; WHEELCHAIR, MECHANICAL

Model Number TRHD22FR

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

The end user alleges the upholstery is ripped due to the metal and plastic bar being bent on a (b)(4) transport chair.

• Brand Name: HVY DUTY TRANSPORT 22 IN-W/FTRST 9153643753
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4450082
• MDR Text Key: 5386720
• Report Number: 1531186-2015-00569
• 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: Patient
• Type of Report: Initial
• Report Date: 01/26/2015,01/19/2015

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 Number: TRHD22FR
• 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: 01/26/2015
• Distributor Facility Aware Date: 01/19/2015
• Date Report to Manufacturer: 01/26/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 107