MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-31 for YELLOFIN STIRRUPS WITHOUT LIFT ASSIST O-YFSI manufactured by Allen Medical Systems, Inc..
[16910430]
Allen medical systems received a medwatch report ((b)(4)) from fda which had been submitted in regard to an issue reported to occur at (b)(6). The following issue was reported in regard to the allen yellofin stirrup: "event desc: there have been problems with staff over tightening the bracket which wears the "teeth" down so it will not hold up well as it should. A possible design flaw with yellofin. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working)". No serial number was provided. The device was not made available to allen medical for eval. No pt involvement was reported. No complaint was made to allen medical systems by the reporter, (b)(6). The yellofin stirrup does not have teeth nor a bracket which is tightened during setup or use. No other customer complaints have been reported to allen medical regarding this problem. Phone contact was made with (b)(6) on (b)(6) 2013 and she was not able to clarify the nature of the reported event/issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221538-2013-00011 |
| MDR Report Key | 3307820 |
| Report Source | 06 |
| Date Received | 2013-07-31 |
| Date of Report | 2013-07-01 |
| Date of Event | 2012-12-17 |
| Date Mfgr Received | 2013-07-01 |
| Date Added to Maude | 2013-09-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 100 DISCOVERY WAY |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal | 01720 |
| Manufacturer Phone | 8885214277 |
| Manufacturer G1 | ALLEN MEDICAL SYSTEMS, INC. |
| Manufacturer Street | ONE POST OFFICE SQUARE |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01720 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YELLOFIN STIRRUPS WITHOUT LIFT ASSIST |
| Generic Name | STIRRUPS |
| Product Code | EYD |
| Date Received | 2013-07-31 |
| Model Number | O-YFSI |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | ONE POST OFFICE SQUARE ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-31 |