MAUDE Adverse Event Report: ANI [ A&I ] GROUP TAIWAN MECHANICAL (MANUAL) WHEELCHAIR; 890.3850

Model Number IN88AHANFR

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Per provider out of box failure 1 of the wheels are warped replace chair.

• Brand Name: MECHANICAL (MANUAL) WHEELCHAIR
• Type of Device: 890.3850
• Manufacturer (Section D): ANI [ A&I ] GROUP TAIWAN; no. 1 been ting; been tsuoh village; chia-yi shiann ; TW
• MDR Report Key: 4043578
• MDR Text Key: 4861364
• Report Number: 1531186-2014-03620
• 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: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/27/2014,08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IN88AHANFR
• 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: 08/27/2014
• Distributor Facility Aware Date: 08/01/2014
• Device Age: 1 YR
• Date Report to Manufacturer: 08/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other