MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-11 for CONTEC POCKET FETAL DOPPLER FD-200B manufactured by Contec Medical System Co. Ltd..
[105416483]
My cousin purchased the "facelake fd-200b baby heartbeat monitor sound amplifier, listening to unborn baby's heartbeat, movements, kicks and hiccups from (b)(4). After my cousin gifted us the product we tried to use it and were very anxious to listen to our baby's heartbeat. We couldn't find it after several tries and immediately my wife had a panic attack and thought something happened to the baby. We then took the product to our doctor to make sure that everything with the baby was fine and our doctor strongly advised that this item is for professional use and our doctor was wondering where we bought it. Once we got home we did some research of our own and we were shocked to realize that this product is actually not recommended by fda and only available with a prescription. This had me thinking, how could someone on (b)(4) sell a product to the public without a prescription especially when it is harmful without a medical professionals supervision. The device she bought was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076429 |
| MDR Report Key | 7424840 |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-04-06 |
| Date Added to Maude | 2018-04-12 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | CONTEC POCKET FETAL DOPPLER |
| Generic Name | MONITOR, ULTRASONIC, FETAL |
| Product Code | KNG |
| Date Received | 2018-04-11 |
| Model Number | FD-200B |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONTEC MEDICAL SYSTEM CO. LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-04-11 |