MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-25 for DEROYAL * 9604-48 manufactured by Deroyal Industries, Inc..
[1219084]
A package containing a sterile stockinette was opened and a flea was found inside the package.
Patient Sequence No: 1, Text Type: D, B5
[1237972]
A package containing a sterile stockinette was opened and a flea was found inside the package.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1492541 |
| MDR Report Key | 1492541 |
| Date Received | 2009-09-25 |
| Date of Report | 2009-09-25 |
| Date of Event | 2009-09-21 |
| Report Date | 2009-09-25 |
| Date Reported to FDA | 2009-09-25 |
| Date Added to Maude | 2009-10-06 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | STOCKINETTE, STANDARD |
| Product Code | FQL |
| Date Received | 2009-09-25 |
| Model Number | * |
| Catalog Number | 9604-48 |
| Lot Number | 18768317 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-25 |