MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-17 for UNKNOWN manufactured by Unknown.
[16168108]
Patient was in a wheelchair, and wheeled herself up to a set of parallel bars with a threshold. When the wheelchair rolled over the threshold, the wheelchair tipped back resulting in a head injury. The event occurred in 2008. A letter dated 8/09 was received alleging equipment contributed to the injury. Investigation pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012796 |
| MDR Report Key | 1481573 |
| Date Received | 2009-09-17 |
| Date of Report | 2009-09-17 |
| Date of Event | 2008-12-14 |
| Date Added to Maude | 2009-09-25 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | PARALLEL BARS |
| Product Code | IOE |
| Date Received | 2009-09-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-09-17 |