MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-12 for YELLOFINS STIRRUPS WITHOUT LIFT ASSIST * #O-YFSI manufactured by Allen Medical Systems.
[3554671]
There have been problems with staff over tightening the bracket which wears the "teeth" down so it will not hold up as well as it should. A possible design flaw with yellofin. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3189852 |
| MDR Report Key | 3189852 |
| Date Received | 2013-06-12 |
| Date of Report | 2013-03-05 |
| Date of Event | 2012-12-17 |
| Report Date | 2013-03-05 |
| Date Reported to FDA | 2013-06-12 |
| Date Reported to Mfgr | 2013-06-26 |
| Date Added to Maude | 2013-06-26 |
| 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 | 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 | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YELLOFINS STIRRUPS WITHOUT LIFT ASSIST |
| Generic Name | STIRRUPS |
| Product Code | EYD |
| Date Received | 2013-06-12 |
| Model Number | * |
| Catalog Number | #O-YFSI |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL SYSTEMS |
| Manufacturer Address | ONE POST OFFICE SQUARE ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-12 |