MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-01-19 for UNKNOWN manufactured by Unk.
[16258484]
Pt 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 that required surgery. The event occurred on (b)(6) 2008. A letter dated (b)(6) was rec'd alleging equipment contributed to the injury. Investigation pending. This original report was submitted on (b)(6) 2009 as a voluntary reporting using form fda 3500 instead of form fda 3500a. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1659875 |
| MDR Report Key | 1659875 |
| Report Source | 99 |
| Date Received | 2010-01-19 |
| Date of Report | 2010-01-18 |
| Date of Event | 2008-12-14 |
| Date Facility Aware | 2008-12-14 |
| Report Date | 2010-01-18 |
| Date Added to Maude | 2010-04-19 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | PARALLEL BARS |
| Product Code | IOE |
| Date Received | 2010-01-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-01-19 |