MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-18 for BABYDOPPLER SONO LINE B manufactured by Contec Medical Systems.
[120976974]
I purchased a product as a gift for my sister who is expecting living in (b)(6). I came across the product on advertisement on (b)(6) advertising as a cool product for pregnant ladies to hear their unborn baby. I purchased the product through a us supplier and was shipped to my sister in 3 days. She used the product and she had symptoms of severe nausea. She took the device to her doctor and she was advised strongly against the use of this device as it has emission of waves. It was a real shock to her and to me as the person who would be to blame for anything bad happening to baby. I searched online and by surprise, i saw the fda of this device only allows the device to be used by prescription. No where on the website i was asked to provide prescription or event the smallest hint. I tried to reach out the supplier by email, but no hope or response. We have been severly traumatized by this incident. Hope this prevents other folks going through the same bad experience. Www. Babydoppler. Com.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079885 |
| MDR Report Key | 7889327 |
| Date Received | 2018-09-18 |
| Date of Report | 2018-09-16 |
| Date of Event | 2018-09-06 |
| Date Added to Maude | 2018-09-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 |
| Generic Name | BABYDOPPLER |
| Product Code | KNG |
| Date Received | 2018-09-18 |
| Model Number | SONO LINE B |
| Catalog Number | B |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONTEC MEDICAL SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-18 |