MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for DEROYAL VENOUS PACK TRAY 89-8672.01 manufactured by Deroyal Industries, Inc..
[112321418]
Sterile tray was in use and black "speck. " about 0. 5 cm long was on sterile tray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078026 |
| MDR Report Key | 7633780 |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-06-16 |
| Date Added to Maude | 2018-06-25 |
| 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 CAREGIVERS |
| 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 VENOUS PACK TRAY |
| Generic Name | TRAY, SURGICAL |
| Product Code | LRP |
| Date Received | 2018-06-22 |
| Catalog Number | 89-8672.01 |
| Lot Number | 47220975 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-22 |