MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-17 for DEROYAL 89-5525 manufactured by Deroyal Industries, Inc..
[120415971]
A percutaneous tray pack was opened. Inside the pack, there were 7 small sponges when there should have only been 5. The small sponges were removed from the field and placed in a bag with the packaging label for the pack and given to the charge nurse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7880956 |
| MDR Report Key | 7880956 |
| Date Received | 2018-09-17 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-09-06 |
| Report Date | 2018-09-11 |
| Date Reported to FDA | 2018-09-11 |
| Date Reported to Mfgr | 2018-09-17 |
| Date Added to Maude | 2018-09-17 |
| 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 | DEROYAL |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2018-09-17 |
| Model Number | 89-5525 |
| Lot Number | 47941027 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LN. POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-17 |