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

Model Number 501-5012-0200

Device Problem Device Maintenance Issue (1379)

Patient Problem Skin Tears (2516)

Event Date 08/10/2016

Event Type  malfunction  

Event Description

End user stated he was trying to roll the unit in the grass and had to pick it up because it would not roll.When the unit was picked up, the end of the brake cable cut his leg.The end user got a 3.5" cut, which required 8 stitches.End user stated there was no cap on the end of either brake cable.He has taped the end.

• Brand Name: EUROSTYLE ROLLATOR BLACK
• Type of Device: EUROSTYLE ROLLATOR BLACK
• Manufacturer (Section D): RALON MEDICAL EQUIPMENT CO LTD; xilian development zone; jinsha, danzao town; foshan guangdong, cn-44 52822 2; CH 528222
• MDR Report Key: 5954238
• MDR Text Key: 54884412
• Report Number: 1422443-2016-00005
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• 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: 6154270713
• 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: 09/15/2016
• Distributor Facility Aware Date: 08/15/2016
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 09/15/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1