MAUDE Adverse Event Report: FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. DAILY ACTIVITY ASSIST DEVICE

Model Number 7740P

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Per importer's mdr: it was reported that a trapeze bar bent during use.There was no report of injury or medical intervention.

• Brand Name: DAILY ACTIVITY ASSIST DEVICE
• Type of Device: DAILY ACTIVITY ASSIST DEVICE
• Manufacturer (Section D): FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.; new city district, danzao; nanhai, foshan 52821 6; CH 528216
• Manufacturer (Section G): FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.; new city district, danzao; nanhai, foshan 52821 6; CH 528216
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7029625412
• MDR Report Key: 6199809
• MDR Text Key: 63559320
• Report Number: 1000282279-2014-00029
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7740P
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1