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

Model Number 9675-1

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

Per importer's mdr: it was reported that the suction cup of the transfer bench have come off.

• Brand Name: DAILY ACTIVITY ASSIST DEVICE
• Type of Device: TRANSFER BENCH
• Manufacturer (Section D): FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.; new city district, danzao; nanhai, foshan 5282 16; CH 528216
• Manufacturer (Section G): FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.; new city district, danzao; nanhai, foshan 5282 16; CH 528216
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 4953973
• MDR Text Key: 20041319
• Report Number: 1000282279-2014-00005
• 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: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9675-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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