MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2019-06-03 for INTRAOPERATRIVE PROBE COVER PC1290 manufactured by Ecolab.
| Report Number | 8043817-2019-40020 |
| MDR Report Key | 8662718 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2019-06-03 |
| Date of Report | 2019-06-03 |
| Date of Event | 2019-05-16 |
| Date Added to Maude | 2019-06-03 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRAOPERATRIVE PROBE COVER |
| Generic Name | PROBE COVER |
| Product Code | KKX |
| Date Received | 2019-06-03 |
| Model Number | PC1290 |
| Lot Number | D190229 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ECOLAB |
| Manufacturer Address | 1 ECOLAB PLACE ST PAUL MN 55102 US 55102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-03 |