MAUDE Adverse Event Report: THE STANDING COMPANY SUPERSTAND; STAND UP WHEELCHAIR

Model Number HPS-2

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 05/29/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, patient (b)(6) female (b)(6) contacted tsc to advise she incurred an ankle injury.She received outpatient hospitalization to insert a plate and screws into her ankle.She is not certain when she incurred the injury as she is quadriplegic.Her interaction with tsc occurred 27 days earlier in the outpatient rehabilitation department of her local hospital on (b)(6) 2015.

Manufacturer Narrative

Patient said she thinks the break happened during her trial demonstration of standing wheelchair (four (4) weeks earlier), but she is not totally sure.Patient did not seem accusatory or upset during the conversation with her on (b)(6).Rather, patient seemed frustrated/depressed at this setback to the beginning of a standing program.

• Brand Name: SUPERSTAND
• Type of Device: STAND UP WHEELCHAIR
• Manufacturer (Section D): THE STANDING COMPANY; saginaw MI
• Manufacturer Contact: 5848 dixie highway; saginaw, MI 48601 ; 9897469100
• MDR Report Key: 4914769
• MDR Text Key: 6013042
• Report Number: 3007494904-2015-00001
• Device Sequence Number: 1
• Product Code: IPL
• Combination Product (y/n): N
• PMA/PMN Number: K032101
• 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: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: HPS-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2015
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 127