MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for MALEM BEDWETTING ALARM ULTIMATE ALARM manufactured by Malem Medical Ltd..
[183290964]
Malem bedwetting alarm is too hot to hold and operate. I used the batteries that came with the alarm and it turned too hot to hold. I replaced with (b)(6) batteries (new) but same thing happened. This is a dangerous device. If my daughter is sleeping how can i use this alarm on her. It may burn her skin. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093670 |
| MDR Report Key | 9818391 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-08 |
| Date of Event | 2020-03-06 |
| Date Added to Maude | 2020-03-11 |
| 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 | 3 |
| Brand Name | MALEM BEDWETTING ALARM |
| Generic Name | ALARM CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2020-03-10 |
| Model Number | BEDWETTING ALARM |
| Catalog Number | ULTIMATE ALARM |
| 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 | 2020-03-10 |