MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-10-05 for POSEY WAIST SOFT RESTRAINT UNKNOWN 4125 manufactured by J.t. Posey Company.
[18140904]
Alzheimer's patient placed on bed with soft posey waist belt properly applied. During night, patient dipped one arm up and under waist belt and freed belt from left side. Patient tried to get out of bed over side rails, and soft waist belt slipped up throat, interfering with respiratory efforts. Patient expireddevice not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown. Conclusion: no failure detected and product within specification, there was no device failure, none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1535 |
| MDR Report Key | 1535 |
| Date Received | 1992-10-05 |
| Date of Report | 1992-09-28 |
| Date of Event | 1992-09-19 |
| Date Facility Aware | 1992-09-19 |
| Report Date | 1992-09-28 |
| Date Reported to FDA | 1992-09-28 |
| Date Reported to Mfgr | 1992-09-28 |
| Date Added to Maude | 1992-10-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSEY WAIST SOFT RESTRAINT |
| Generic Name | POSEY |
| Product Code | BRT |
| Date Received | 1992-10-05 |
| Model Number | UNKNOWN |
| Catalog Number | 4125 |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1468 |
| Manufacturer | J.T. POSEY COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1992-10-05 |