MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number RTL10289RD

Device Problem Fracture (1260)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 09/20/2019

Event Type  Injury  

Event Description

(b)(6) healthcare is the initial importer of the device which is a rollator.The end-user discarded two units.Both units were discarded making us unable to perform an evaluation.The caregiver advised that the end-user had two of these devices and both units the bolt broke in half leaving part of the bolt in the stem while, she was walking with the unit.Both times she reportedly fell.In one instance the end-user went doctor several times.In the second instance was taken to the er and then for follow up treatment at her primary care doctor.She hit her nose on the concrete and hurt her right leg, which got infected.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9384732
• MDR Text Key: 168435368
• Report Number: 2438477-2019-00076
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383259338
• UDI-Public: 822383259338
• 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: 11/27/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL10289RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/27/2019
• Distributor Facility Aware Date: 09/27/2019
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR