MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-01 for SONOLINE B manufactured by Unk.
[93803299]
I am (b)(6) weeks pregnant - in a forum i came to know about a product called babydoppler - i purchased it online on this website: (b)(6). Company is us based and they shipped it to my address. I used the device as shown on the video in the website - after 15 minutes using the probe trying to spot the baby's heartbeat i had a feeling of burning on my skin - after that i found a burn mark on my skin as big as the size of a coin. I was really afraid of the symptoms - i went to my ob and he told me that this device is widely available but was never approved by fda for use by public. The ultrasound device could create deep heat in tissues and harm the unborn baby. I am extremely desperate, stressful, angry and hopeless. I called the company and could not get any response from them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073720 |
| MDR Report Key | 7079119 |
| Date Received | 2017-12-01 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-11-28 |
| Date Added to Maude | 2017-12-04 |
| 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 |
| Generic Name | BABYDOPPLER |
| Product Code | KNG |
| Date Received | 2017-12-01 |
| Model Number | B |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Life Threatening; 3. Other | 2017-12-01 |