MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-03 for POSEY NONSKID SOCKS 6239R manufactured by Posey Company.
[46767062]
The non-skid pads on the bottom of the posey socks that are used for our high fall risk patients did not have enough non-skid material causing the sock to be slippery and increase the risk for falls. The company was made aware when it was realized that potentially 2 patients had been affected by the defect. We are unsure how long this had been occurring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062682 |
| MDR Report Key | 5702730 |
| Date Received | 2016-06-03 |
| Date of Report | 2016-05-24 |
| Date of Event | 2016-05-12 |
| Date Added to Maude | 2016-06-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POSEY NONSKID SOCKS |
| Generic Name | NONSKID SOCKS |
| Product Code | FQL |
| Date Received | 2016-06-03 |
| Catalog Number | 6239R |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY COMPANY |
| Manufacturer Address | ARCADIA CA US |
| Brand Name | POSEY NONSKID SOCKS |
| Generic Name | NONSKID SOCKS |
| Product Code | FQL |
| Date Received | 2016-06-03 |
| Catalog Number | 6239Y |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | POSEY COMPANY |
| Manufacturer Address | ARCADIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-03 |