MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON TRAM; TRANSFER AND MOBILITY DEVICE

Model Number K320

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2021

Event Type  malfunction  

Event Description

It was reported that the buckle securing the body support no longer functions.

• Brand Name: RIFTON TRAM
• Type of Device: TRANSFER AND MOBILITY DEVICE
• Manufacturer (Section D): RIFTON EQUIPMENT; 103 woodcrest drive; rifton NY 12471
• Manufacturer (Section G): RIFTON EQUIPMENT; 103 woodcrest drive; rifton NY 12471
• Manufacturer Contact: travis scott ; 103 woodcrest drive; rifton, NY 12471 ; 8456587722
• MDR Report Key: 11710773
• MDR Text Key: 260686362
• Report Number: 1319061-2021-00005
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: K320
• Device Catalogue Number: K320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 82607
• Patient Sequence Number: 1