MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-26 for POSEY PASTEL COTTON GAIT 6531 manufactured by Posey Products Llc.
[180847935]
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.
Patient Sequence No: 1, Text Type: N, H10
[180847936]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2020-00009 |
| MDR Report Key | 9753313 |
| Report Source | OTHER |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-04 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-02-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS RAHN |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207514300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSEY PASTEL COTTON GAIT |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2020-02-26 |
| Model Number | 6531 |
| Catalog Number | 6531 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 570 ENTERPRISE DRIVE NEENAH WI 54956 US 54956 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-26 |