MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for ENDOCLEAR RESTORE EC-100-01 manufactured by Avanos Medical, Inc..
| Report Number | 3011270181-2019-00044 |
| MDR Report Key | 9148093 |
| Date Received | 2019-10-02 |
| Date of Report | 2019-09-24 |
| Date of Event | 2018-01-22 |
| Date Mfgr Received | 2019-09-24 |
| Date Added to Maude | 2019-10-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | PRO-TECH |
| Manufacturer Street | 14561 MARQUARDT AVENUE |
| Manufacturer City | SANTA FE SPRINGS CA 90670 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90670 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDOCLEAR RESTORE |
| Generic Name | TRACHEOBRONCHIAL SUCTION CATHETER |
| Product Code | BSY |
| Date Received | 2019-10-02 |
| Model Number | EC-100-01 |
| Lot Number | 9440122 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL, INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-02 |