MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-06 for BABYDOPPLER SONOLINE manufactured by Unk.
[116519252]
Our establishment provides helps and support to existing parents under midwifery services. We have witnessed this issue before and it has been on rise recently. Expecting parents (our clients) contact us with severe anxiety. Apparently they buy products which are available in the market under fetal monitor. The devices are not accurate and leads to severe anxiety as moms think they have lost the baby. They try for prolonged period of time trying to find their fetus heartbeat. When they fail, they start looking at the note from fda warning against the use of this device. The note on potential damage to unborn baby makes them more panicked which all is a severe stress and emotional damage on expecting parents. We have faced several cases and would like to address public safety. The products are available from variety of resources including (b)(6) and other websites like (b)(6). Https://www. Fda. Gov/forconsumers/consumersupdates/ucm095508. Htm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078922 |
| MDR Report Key | 7757622 |
| Date Received | 2018-08-06 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-07-11 |
| Date Added to Maude | 2018-08-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BABYDOPPLER SONOLINE |
| Generic Name | MONITOR, ULTRASONIC, FETAL |
| Product Code | KNG |
| Date Received | 2018-08-06 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-06 |