MAUDE Adverse Event Report: SHUNLONG PHYSICAL THERAPY EQUIPMENT DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 6358

Device Problem Out-Of-Box Failure (2311)

Patient Problem Laceration(s) (1946)

Event Type  No Answer Provided  

Event Description

Dealer reports the cuff of the piece that goes around the bottom of frame near the casters, does not fit and is sticking out, and sharp, states techs putting chairs together cut themselves on the metal, both units in this carton were the same way.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): SHUNLONG PHYSICAL THERAPY EQUIPMENT; shanghai ; CH
• MDR Report Key: 4168272
• MDR Text Key: 5023933
• Report Number: 1531186-2014-04898
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/13/2014,09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6358
• 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: 10/13/2014
• Distributor Facility Aware Date: 09/24/2014
• Device Age: 8 MO
• Date Report to Manufacturer: 10/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other