MAUDE Adverse Event Report: FOSHAN NANHAI R. POON MEDICAL PRODUCTS CO., LTD. ROLLING WALKER; ROLLATOR

Model Number FGA22200 0000

Device Problem Defective Component (2292)

Patient Problem Head Injury (1879)

Event Date 03/04/2016

Event Type  Injury  

Event Description

The customer called to report that they were sitting on their rollator, bending over to pick something up at a store, when the right front wheel popped off on the device.The customer is reporting that they bumped their head.The customer went to the doctor and was instructed to go to the emergency room.The customer's device was returned to (b)(4) on (b)(4) 2016 for further evaluation.The unit was inspected, and was found to have had normal wear - apart from where it was broken.The customer stated that the front right wheel had popped off.The returns inspector found that the right wheel appeared to have unscrewed from the frame, resulting in the wheel falling off.There were no signs of the bolt or threads in the frame being stripped.The wheel and frame had no signs of being dented or damaged.The right side handle bar was also broken where it slides into the frame.The handle bar appears to have had a lot of pressure on its side for it to have snapped off like it did.Overall, the customer's complaint could be confirmed.

• Brand Name: ROLLING WALKER
• Type of Device: ROLLATOR
• Manufacturer (Section D): FOSHAN NANHAI R. POON MEDICAL PRODUCTS CO., LTD.; new city district; danzao, nanhai; foshan guangdong, 52821 6; CH 528216
• MDR Report Key: 5526494
• MDR Text Key: 41176099
• Report Number: 2182780-2016-00002
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA22200 0000
• Device Catalogue Number: A222-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2016
• Distributor Facility Aware Date: 03/04/2016
• Event Location: Other
• Date Report to Manufacturer: 03/25/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention