MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-29 for ECOLAB ORS-320 manufactured by Microtek Medical, Inc..
[104069247]
During case, circulator noticed saline in warmer not contained in sterile drape.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076216 |
| MDR Report Key | 7384651 |
| Date Received | 2018-03-29 |
| Date of Report | 2018-03-06 |
| Date of Event | 2018-02-14 |
| Date Added to Maude | 2018-03-30 |
| 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 HEALTH CARE PROFESSIONAL |
| 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 | ECOLAB |
| Generic Name | SLUSH+WARMER DISC - DRAPE |
| Product Code | LHC |
| Date Received | 2018-03-29 |
| Catalog Number | ORS-320 |
| Lot Number | D172361 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK MEDICAL, INC. |
| Manufacturer Address | 602 LEHMBERG RD. COLUMBUS MS 39702 US 39702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-29 |