MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-24 for DEROYAL 89-3151.19 manufactured by Deroyal.
[76147197]
Sterile specials tray lot #43794066 was opened for an arteriogram procedure. Small black spec and small clear piece of fuzz noted in the bottom guidewire bowl. The small spec and fuzz were collected and placed on a 4x4 gauze and placed into the sterile clear cup and covered with the lid. No items from this tray came in contact with patient. Once the spec was noted, the sharps were removed and the tray was removed from the room. A new tray was opened and used for this procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070025 |
| MDR Report Key | 6593563 |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-24 |
| Date of Event | 2017-05-23 |
| Date Added to Maude | 2017-05-26 |
| 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 |
| 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 | 0 |
| Brand Name | DEROYAL |
| Generic Name | SPECIALS TRAY |
| Product Code | LRP |
| Date Received | 2017-05-24 |
| Returned To Mfg | 2017-05-24 |
| Model Number | 89-3151.19 |
| Lot Number | 43794066 |
| Device Expiration Date | 2018-07-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL |
| Manufacturer Address | POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-24 |