MAUDE Adverse Event Report: RALON MEDICAL EQUIPMENT CO LTD HEALTHSMART; HEALTHSMART EUROSTYLE ROLLATOR BLACK

Model Number 501-5012-0200

Device Problems Use of Device Problem (1670); No Apparent Adverse Event (3189)

Patient Problem Fall (1848)

Event Date 11/24/2020

Event Type  malfunction  

Event Description

It was reported that the unit's backrest broke, causing the end user to fall backwards and hit her head on the concrete patio, along with the top of her left hip.The end user also got a cut on her left hand.The unit has been in service for 23 months.This product has a 300 pound weight capacity and a 3-year warranty.No medical intervention was sought.As of this submission, the sample has not been received for evaluation.

Event Description

This is a follow-up report.

Manufacturer Narrative

Based on the specification that the backstrap can withstand 150% of the stated load, we believe this product failure is attributable to over-utilization and abnormal use.We will close this record and continue to trend for any indications of manufacturing related defects.

• Brand Name: HEALTHSMART
• Type of Device: HEALTHSMART EUROSTYLE ROLLATOR BLACK
• Manufacturer (Section D): RALON MEDICAL EQUIPMENT CO LTD; xillan development zone; danzo nanhai; foshan, guangdong 52822 2; CH 528222
• MDR Report Key: 11066558
• MDR Text Key: 224394789
• Report Number: 1422443-2020-00007
• 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
• Type of Report: Initial,Followup
• Report Date: 01/29/2021,12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 501-5012-0200
• Device Catalogue Number: 501-5012-0200
• Device Lot Number: 6154270318
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2021
• Distributor Facility Aware Date: 11/27/2020
• Device Age: 23 MO
• Event Location: Home
• Date Report to Manufacturer: 01/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 67