MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-05 for POSTURE GUARD UNKNOWN PS-1302 manufactured by Luxury Liners.
[2149]
Patient was sitting in wheelchair in front of room after breakfast, fell forward out of wheelchair and hit head on floor, due to broken chest posture guard. Cold pack to right temple, temporary restraint applieddevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. Date last serviced: 01-jan-92. Service provided by: other. Service records available. 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, other. Results of evaluation: manufacturing. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954 |
| MDR Report Key | 2954 |
| Date Received | 1992-08-05 |
| Date of Report | 1992-08-03 |
| Date of Event | 1992-03-02 |
| Date Facility Aware | 1992-03-02 |
| Report Date | 1992-08-03 |
| Date Added to Maude | 1993-04-02 |
| 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 | POSTURE GUARD |
| Generic Name | UNKNOWN |
| Product Code | KNO |
| Date Received | 1992-08-05 |
| Model Number | UNKNOWN |
| Catalog Number | PS-1302 |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Device Availability | * |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2767 |
| Manufacturer | LUXURY LINERS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-08-05 |