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

Model Number TRHD22FR

Device Problem Torn Material (3024)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Type  Injury  

Event Description

Daughter of the end user reported that while her mother was sitting in the trhd22fr transport chair the seat fabric ripped causing her to fall through an land on the floor.The end user did go to the er but was found to be fine other then some bruising.

• Brand Name: HVY DUTY TRANSPORT 22 IN-W/FTRST 9153643753
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4519966
• MDR Text Key: 5406677
• Report Number: 1531186-2015-00999
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 02/16/2015,02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 02/16/2015
• Distributor Facility Aware Date: 02/12/2015
• Date Report to Manufacturer: 02/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 64