MAUDE Adverse Event Report: UNKNOWN DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 96-2

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Customer states the rear left leg is bent.Customer didn't have a lot number but states the unit was sold 3/26/2013.She states its a bent on the frame portion not the lower leg.Customer has no reported injuries.Customer states she purchases through (b)(6).Advised replacement item will be ordered through them.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 3971379
• MDR Text Key: 4636038
• Report Number: 1531186-2014-02913
• Device Sequence Number: 1
• Product Code: IKX
• 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: Patient
• Type of Report: Initial
• Report Date: 07/30/2014,06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 96-2
• 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: 07/30/2014
• Distributor Facility Aware Date: 06/25/2014
• Date Report to Manufacturer: 07/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other