MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-24 for YELLOFIN STIRRUPS manufactured by Allen Medical Systems, Inc..
[133953360]
Yellofin stirrup- this is a positioning device. The device drifted inward during case. It has been used for two procedures and it happened both times. It has been sent to vendor for repair. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8273169 |
| MDR Report Key | 8273169 |
| Date Received | 2019-01-24 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-12-21 |
| Report Date | 2019-01-02 |
| Date Reported to FDA | 2019-01-02 |
| Date Reported to Mfgr | 2019-01-24 |
| Date Added to Maude | 2019-01-24 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YELLOFIN STIRRUPS |
| Generic Name | SUPPORT, PATIENT POSITION |
| Product Code | CCX |
| Date Received | 2019-01-24 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 100 DISCOVERY WAY ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-24 |