MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-28 for STIRRUP FOR BED ASSEMBLY manufactured by Unknown.
[34404777]
Patient Sequence No: 1, Text Type: N, H10
[34404778]
Dr was moving the patient's left leg, which was in a stirrup. As dr moved, the entire stirrup came out of the bed attachment and started to fall. Patient's leg never left doctor's hands so no injury to the patient. Maintenance was called to check on the problem and found no problem. There is a quick release for the stirrup assembly that was accidentally bumped. No equipment problem. It was a human factor/user error. There is a quick release for the stirrup assembly that was accidently bumped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5328883 |
| MDR Report Key | 5328883 |
| Date Received | 2015-12-28 |
| Date of Report | 2015-11-23 |
| Date of Event | 2015-11-18 |
| Report Date | 2015-11-23 |
| Date Reported to FDA | 2015-11-23 |
| Date Reported to Mfgr | 2015-11-23 |
| Date Added to Maude | 2015-12-28 |
| 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 |
| 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 | 3 |
| Generic Name | STIRRUP FOR BED ASSEMBLY |
| Product Code | HDD |
| Date Received | 2015-12-28 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-28 |