MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-17 for DEROYAL ESMARK BANDAGES 30-196 manufactured by Deroyal Industries.
| Report Number | 3014527682-2020-00004 |
| MDR Report Key | 9844833 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS CHEYENNE STEWART |
| Manufacturer Street | 3000 EAST SAWYER ROAD |
| Manufacturer City | REPUBLIC, MO |
| Manufacturer Country | US |
| Manufacturer Phone | 7303937 |
| Manufacturer G1 | ROI CPS, LLC |
| Manufacturer Street | 3000 EAST SAWYER ROAD |
| Manufacturer City | REPUBLIC, MO |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL ESMARK BANDAGES |
| Generic Name | ESMARK, BANDAGE 4X9FT |
| Product Code | FQM |
| Date Received | 2020-03-17 |
| Catalog Number | 30-196 |
| Lot Number | 50118138 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES |
| Manufacturer Address | POWELL, TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |