MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-24 for HERO H-100 manufactured by Hero Health, Inc..
| Report Number | 3014660737-2019-90001 |
| MDR Report Key | 8729509 |
| Date Received | 2019-06-24 |
| Date of Report | 2019-06-24 |
| Date of Event | 2019-05-26 |
| Date Mfgr Received | 2019-05-29 |
| Device Manufacturer Date | 2019-05-01 |
| Date Added to Maude | 2019-06-24 |
| 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. HAR KHARA |
| Manufacturer Street | 160 VARICK ST STE 1004 |
| Manufacturer City | NEW YORK CITY NY 10013 |
| Manufacturer Country | US |
| Manufacturer Postal | 10013 |
| Manufacturer Phone | 4082046534 |
| Manufacturer G1 | SONIC MANUFACTURING TECHNOLOGIES |
| Manufacturer Street | 47951 WESTINGHOUSE DR |
| Manufacturer City | FREMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94539 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HERO |
| Generic Name | HERO DISPENSER - SOLID MEDICATION |
| Product Code | NXB |
| Date Received | 2019-06-24 |
| Model Number | H-100 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 27 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERO HEALTH, INC. |
| Manufacturer Address | 160 VARICK ST. STE 1004 NEW YORK CITY NY 10013 US 10013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-06-24 |