MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-10 for SLUSH/WARMER DISC DRAPE ORS-320N manufactured by Ecolab/microtek Medical.
| Report Number | 8043817-2019-40024 |
| MDR Report Key | 8688780 |
| Date Received | 2019-06-10 |
| Date of Report | 2019-06-10 |
| Date of Event | 2019-05-22 |
| Date Added to Maude | 2019-06-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | LAS AMERICAS FREE ZONE PARK KM 22 |
| Manufacturer City | SANTO DOMINGO, 11606 |
| Manufacturer Country | DR |
| Manufacturer Postal | 11606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SLUSH/WARMER DISC DRAPE |
| Generic Name | SURGICAL DRAPE |
| Product Code | KKX |
| Date Received | 2019-06-10 |
| Model Number | ORS-320N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ECOLAB/MICROTEK MEDICAL |
| Manufacturer Address | 1 ECOLAB PLACE ST PAUL MN 55102 US 55102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-10 |