MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-09 for SONOLINE B HEARTBEAT MONITOR BY BABYDOPPLER ASIN NUMBER manufactured by Unk.
[99901805]
I purchased this product as i was browsing (b)(4) and i read some customer reviews. The device claims to be using to hear fetus heartbeat in pregnancy. I purchased the device and it was shipped to our address. I used the device 3-4 times then on internet i came across an article by an obstetrician advising strongly against the use of this device even damage to unborn babies. I have called the supplier which is (b)(4) and the staff over the phone were unable to advice me if this device is for home use. As an expecting mom experiencing so much anxiety this device has been marketed without any medical proof and safety. (b)(4) item number is: b073wkdt2h.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075189 |
| MDR Report Key | 7263389 |
| Date Received | 2018-02-09 |
| Date of Report | 2018-02-08 |
| Date of Event | 2018-01-18 |
| Date Added to Maude | 2018-02-12 |
| 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 | SONOLINE B HEARTBEAT MONITOR BY BABYDOPPLER |
| Generic Name | MONITOR, ULTRASONIC FETAL |
| Product Code | KNG |
| Date Received | 2018-02-09 |
| Model Number | BABYDOPPLER |
| Catalog Number | ASIN NUMBER |
| Lot Number | B073WKDT2H |
| Operator | LAY USER/PATIENT |
| 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 | 2018-02-09 |