MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-10 for UNABLE TO DETERMINE manufactured by .
[39756167]
Resident was working at the parallel bars when the bar on the left slid inward causing her to fall. The resident struck the back of her head on the other bar. No injury resulted. The screw holding the bar at the joint had come loose. She had been working at the bars for approx. 10 minutes when the bar slid. Maintenance dept secured bars - additional safety screws added.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5479696 |
| MDR Report Key | 5479696 |
| Date Received | 2005-06-10 |
| Date of Report | 2005-06-09 |
| Date of Event | 2005-05-10 |
| Date Facility Aware | 2005-05-10 |
| Report Date | 2005-06-09 |
| Date Reported to FDA | 2005-06-09 |
| Date Added to Maude | 2016-03-04 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNABLE TO DETERMINE |
| Generic Name | PARALLEL BARS |
| Product Code | IOE |
| Date Received | 2005-06-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 20 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-10 |