MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-31 for ENURESIS ALARM ULTIMATE 1 TONE manufactured by Malem Medical Ltd..
[173574108]
This complaint is regarding the malem bedwetting alarm (1 tone) which i am attempting to use for the first time. I followed the instructions and put in batteries. Then i lifted the sensor lever and inserted the sensor inside the alarm but as soon as i do that, the alarm makes a strange sound like something is stuck and within a few mins, the alarm gets hot. Also, there is a bad smell of burning from the alarm. I gave it 20 mins and the alarm was hot. I could have burned my hand. I then removed the batteries and replaced them, but same thing happened. How can this device be safely used if it is getting so hot. It's unsafe for my (b)(6) year old daughter. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091997 |
| MDR Report Key | 9540208 |
| Date Received | 2019-12-31 |
| Date of Report | 2019-12-29 |
| Date of Event | 2019-12-29 |
| Date Added to Maude | 2020-01-02 |
| 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 | 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 | 3 |
| Brand Name | ENURESIS ALARM |
| Generic Name | ALARM, CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2019-12-31 |
| Model Number | ULTIMATE 1 TONE |
| Catalog Number | ULTIMATE 1 TONE |
| Lot Number | LIGHT BLUE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALEM MEDICAL LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-31 |