MAUDE Adverse Event Report: ALTIMATE MEDICAL, INC. EASYSTAND EVOLV; STANDING FRAME

Model Number EVOLV MEDIUM

Device Problem Material Integrity Problem (2978)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 10/24/2023

Event Type  Injury  

Event Description

On (b)(6), 2023 altimate medical, inc.Received a notice from a sales representative, there was an issue reported to them.The issue was that the customer claimed his daughter was in the easystand when the lateral rod weldment broke, and she fell out and broke her ankle.The customer was told that a regional manager or that someone from quality would be contacting him for additional information.Quality contacted the customer later that day to gather more information regarding the incident.The customer said the welded peg for the laterals popped off while the caregivers were raising his daughter, startling her which then caused her to fall to the side (in the stander) and also lifted and twisted (rotated) her left ankle and she sustained a slight ankle sprain.The incident occurred on tuesday 10/24/2023.He did not know any injury had occurred until (b)(6) 2023 when they took her to the dr because it had started to swell.The customer said that the doctor said his daughter should stay off of her ankle the rest of that week, but could return to her standing program the next week.The customer communicated that they had seen the doctor again the following day ((b)(6) 2023) and that the doctor had said that his daughter could return to standing on monday ((b)(6) 2023).

Manufacturer Narrative

The device history record for the stander was reviewed.The device was shipped out for the customer on 6/15/2011.The device is more than 7 years past it's expected life of 5 years.Included within the safety precautions section of the owner's manual that is sent with every device, it states that the expected service life of an easystand is outlined to be considered 5 years under normal use conditions.Altimate did not request the entire device to be returned.The back accessory bracket and lateral guides were asked to be returned for the investigation.Those items were returned by the customer.While medical attention was sought, no intervention was required to preclude permanent impairment/damage.The slight sprain would be considered a temporary/reversable impairment (without medical intervention).The case is being reported because of the discrepancies noted between the conversations regarding what injury had occurred.In the initial report from the customer to the sales rep the injury was stated to be a break.In subsequent communication between the customer and quality team member, the injury was identified to be a slight sprain.

• Brand Name: EASYSTAND EVOLV
• Type of Device: STANDING FRAME
• Manufacturer (Section D): ALTIMATE MEDICAL, INC.; 262 west first street; morton MN 56283
• Manufacturer (Section G): ALTIMATE MEDICAL, INC.; 262 west first street; morton 56270
• Manufacturer Contact: amy curtis ; 262 west first street; morton 56270
• MDR Report Key: 18207637
• MDR Text Key: 328959060
• Report Number: 2183634-2023-00002
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVOLV MEDIUM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2011
• 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 Age: 30 YR
• Patient Sex: Female