MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-14 for KOH-EFFICIENT,RUMI KC-RUMI manufactured by Coopersurgical, Inc..
| Report Number | 1216677-2020-00026 |
| MDR Report Key | 9713751 |
| Report Source | OTHER |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2019-10-18 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-14 |
| 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 | MR. PETER NIZIOLEK |
| Manufacturer Street | 50 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL, CT |
| Manufacturer Country | US |
| Manufacturer Phone | 6015200334 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL, CT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOH-EFFICIENT,RUMI |
| Generic Name | KOH-EFFICIENT,RUMI |
| Product Code | HEW |
| Date Received | 2020-02-14 |
| Model Number | KC-RUMI |
| Catalog Number | KC-RUMI |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL, CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-14 |