MAUDE Adverse Event Report: RALON MEDICAL EQUIPMENT CO. LTD. ESSENTIAL ROLLATOR; MECHANICAL WALKER

Model Number RL-A42010 RED

Device Problems Material Deformation (2976); Physical Property Issue (3008)

Patient Problem Laceration(s) (1946)

Event Date 10/01/2015

Event Type  malfunction  

Event Description

Patient was walking to the bathroom in (b)(6) 2015 when she noticed a cut on her outer left leg near the ankle.At the time the cut was observed, the walker was beside her, though she could not recall how her leg may have made contact with the brake plate.The second incident occurred in (b)(6) 2016 when the user was seated in the public library.She moved the walker out of the way of a passerby and in doing so the walker rolled toward her leg.She was cut when one of the brake plates made contact with the inside of her right ankle.The end user required stitches after both incidents.Repeated attempts to retrieve the walker for evaluation have been unsuccessful.

• Brand Name: ESSENTIAL ROLLATOR
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): RALON MEDICAL EQUIPMENT CO. LTD.; xilian development zone; jinsha, danzao town, foshan, guangdong 52822 2; CH 528222
• MDR Report Key: 5970476
• MDR Text Key: 55423330
• Report Number: 1056127-2016-00012
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756130183
• UDI-Public: 754756130183
• 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: 09/22/2016,09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RL-A42010 RED
• Device Catalogue Number: W1700R-11
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2016
• Distributor Facility Aware Date: 09/06/2016
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 09/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 59