MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-17 for DAYSY manufactured by Valley Electronics Ag.
| Report Number | 3011197658-2019-00001 |
| MDR Report Key | 9205972 |
| Date Received | 2019-10-17 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-08-27 |
| Date Facility Aware | 2019-08-27 |
| Report Date | 2019-10-17 |
| Date Reported to FDA | 2019-10-17 |
| Date Reported to Mfgr | 2019-09-24 |
| Date Mfgr Received | 2019-08-27 |
| Device Manufacturer Date | 2018-12-01 |
| Date Added to Maude | 2019-10-17 |
| 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. NIKLAS NATHE |
| Manufacturer Street | MARIENSTRASSE 16 |
| Manufacturer City | ZURICH, 8003 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 8003 |
| Manufacturer G1 | VALLEY ELECTRONICS AG |
| Manufacturer Street | MARIENSTRASSE 16 |
| Manufacturer City | ZURICH, 8003 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DAYSY |
| Generic Name | DAYSY FERTILITY TRACKER |
| Product Code | LHD |
| Date Received | 2019-10-17 |
| Lot Number | 12-2018 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VALLEY ELECTRONICS AG |
| Manufacturer Address | MARIENSTRASSE 16 ZURICH, 8003 SZ 8003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-17 |