MAUDE Adverse Event Report: POSEY PRODUCTS LLC POSEY PASTEL COTTON GAIT; AID, TRANSFER

Model Number 6531

Device Problem Off-Label Use (1494)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The posey gait belt sku 6531 is intended to support patients/residents requiring ambulation and/or transfer assistance.The product is not intended for use as a restraint.Based on the reported description of how this product was used, the event description does not align with the designed intended use of the product.In addition to not aligning to the intended use of the product, the instructions for use also has a direct warning indication to never use a gait or transfer belt as a seat belt or to position a person in a chair.A trend review of the last 6 years of complaint data for this device was performed and found no other complaints related to device misuse.All complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.No corrective or preventative actions are necessary at this time.Manufacturer record # 2020-00181.Unavailable due to ongoing litigation.

Event Description

Posey was contacted by an attorney who is on a case that is about two years old involving a child of about (b)(6) years old with down's syndrome and a seizure disorder who had been strapped to a chair with the posey sku 6531 pastel bouquet gait belt while in school.At some point while in the chair the boy had a seizure and fell over with the chair, severed his spinal cord at c1-c2, and subsequently passed away from this injury.The attorney was trying to reach out to posey to have someone verify that the item 6531 is not to be used as a restraint, i.E.Strapping the child to a chair.The exact date of the death is unknown at this time.

• Brand Name: POSEY PASTEL COTTON GAIT
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): POSEY PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 9753313
• MDR Text Key: 180847935
• Report Number: 2020362-2020-00009
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death