MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-25 for TRUNK SUPPORT manufactured by Ni.
[175376]
Resident was seated in a wheelchair (with an attached trunk support) which was fastened. The resident apparently slid down in the wheelchair and was found with the front of the trunk support under his chin. Staff lifted the resident, to unfasten and remove the trunk support.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 215849 |
| MDR Report Key | 215849 |
| Date Received | 1999-03-25 |
| Date of Report | 1999-03-25 |
| Date of Event | 1999-03-17 |
| Date Facility Aware | 1999-03-17 |
| Report Date | 1999-03-25 |
| Date Reported to FDA | 1999-03-25 |
| Date Added to Maude | 1999-03-26 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | TRUNK SUPPORT |
| Product Code | IMS |
| Date Received | 1999-03-25 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 209384 |
| Manufacturer | NI |
| Manufacturer Address | NI NI * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1999-03-25 |