MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-19 for EXPRESS AIRE manufactured by Rolyan.
[17450068]
Date of event: (b)(6) 2012. Five different pts complaining of pain and bruising in the thigh area. The location of pain and bruising coincides with tourniquet cuff placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027815 |
| MDR Report Key | 2855526 |
| Date Received | 2012-11-19 |
| Date of Report | 2012-11-19 |
| Date of Event | 2012-10-10 |
| Date Added to Maude | 2012-12-05 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPRESS AIRE |
| Generic Name | TOURNIQUET |
| Product Code | GAX |
| Date Received | 2012-11-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROLYAN |
| Manufacturer Address | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-19 |