MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for YELLOFIN STIRRUP manufactured by Allen Medical Systems, Inc..
[133230125]
Patient was positioned in surgery for a laparoscopy. Legs were in yellow fin stirrups. Procedure had started when all of a sudden patient's right leg in the stirrup fell down to the side of table. Leg was caught by dr. And held by nurses. Upon inspection of patient's right leg no injury was noted per dr. The stirrup was then inspected and was found to completely have snapped off at metal attachment to stirrup. Upon inspection of the floor a piece of the metal screw was also found and taped to the stirrup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8252568 |
| MDR Report Key | 8252568 |
| Date Received | 2019-01-16 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-10-24 |
| Report Date | 2018-12-21 |
| Date Reported to FDA | 2018-12-21 |
| Date Reported to Mfgr | 2019-01-16 |
| Date Added to Maude | 2019-01-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 STIRRUP |
| Generic Name | SUPPORT, PATIENT POSITION |
| Product Code | CCX |
| Date Received | 2019-01-16 |
| 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 | 2019-01-16 |