MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL

Model Number LTTB19FR

Device Problem Product Quality Problem (1506)

Patient Problems Fall (1848); Discomfort (2330)

Event Date 06/02/2015

Event Type  Injury  

Event Description

The patient was attempting to sit in the chair.The patient stated the chair slipped free the patient slipped fell hurt his head.The patient was transported by ambulance to hospital.The patient was admitted.The patient was out of the hospital by the weekend.The patient also stated the caregiver attempted to catch him and she hurt her back.She did not seek immediate medical attention and sought it afterward, and allegedly has had to seek medical attention several more times.

• Brand Name: TRANSPORT 20 IN X 16 IN 9153637574
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT; danyang ; CH
• MDR Report Key: 4837532
• MDR Text Key: 5912305
• Report Number: 1531186-2015-01040
• 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: 06/10/2015,06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• 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: 06/10/2015
• Distributor Facility Aware Date: 06/08/2015
• Device Age: 8 MO
• Date Report to Manufacturer: 06/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization