MAUDE Adverse Event Report: ALTIMATE MEDICAL, INC. EASYSTAND BANTAM MEDIUM; CHAIR, POSITIONING, ELECTRIC

Model Number BANTAM MEDIUM

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 07/12/2021

Event Type  Injury  

Event Description

Altimate medical, inc.Was informed by one of their sales representatives on (b)(6) 2021 that a client's father claimed their bantam medium stander was "faulty".The father said the client was standing in it last week and the tray fell off and she fell out of it, injuring herself.He stated that the tray was not able to securely attach to the stander.

• Brand Name: EASYSTAND BANTAM MEDIUM
• Type of Device: CHAIR, POSITIONING, ELECTRIC
• Manufacturer (Section D): ALTIMATE MEDICAL, INC.; 262 west first street; morton MN 56270
• Manufacturer (Section G): ALTIMATE MEDICAL, INC.; 262 west first street; morton MN 56270
• Manufacturer Contact: travis fluck ; 262 west first street; morton, MN 56270 ; 5076976393
• MDR Report Key: 12310956
• MDR Text Key: 266152147
• Report Number: 2183634-2021-00002
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: BANTAM MEDIUM
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 47