MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2019-08-22 for MY DOSE COACH manufactured by Sanofi-aventis Deutschland Gmbh.
| Report Number | 3010770778-2019-00002 |
| MDR Report Key | 8919444 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2019-08-22 |
| Date of Report | 2019-08-21 |
| Date Added to Maude | 2019-08-22 |
| 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 |
| Manufacturer Contact | DR. HEATHER SCHIAPPACASSE |
| Manufacturer Street | 55 CORPORATE DRIVE, MS 55B-220 A |
| Manufacturer City | BRIDGEWATER 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer G1 | SANOFI-AVENTIS DEUTSCHLAND GMBH |
| Manufacturer Street | D-65926 INDUSTRIEPARK HOCHST - BUILDING H500 |
| Manufacturer City | FRANKFURT AM MAIN 65926 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65926 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MY DOSE COACH |
| Generic Name | INSULIN DELIVERY |
| Product Code | NDC |
| Date Received | 2019-08-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SANOFI-AVENTIS DEUTSCHLAND GMBH |
| Manufacturer Address | D-65926 INDUSTRIEPARK HOCHST - BUILDING H500 FRANKFURT AM MAIN 65926 GM 65926 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-08-22 |