MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-31 for MALEM BEDWETTING ALARM M042 ULTIMATE PRO manufactured by Malem Medical Ltd..
[173771075]
The alarm is too hot to operate safely. This is a new malem alarm which i purchased to stop bedwetting in my son. The outside temperature is like a hot bowl removed from the microwave oven. How can he sleep with such a hot object touching him all night? Too dangerous. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091979 |
| MDR Report Key | 9539545 |
| Date Received | 2019-12-31 |
| Date of Report | 2019-12-27 |
| Date of Event | 2019-12-25 |
| 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 | 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 REPSONSE |
| Product Code | KPN |
| Date Received | 2019-12-31 |
| Model Number | M042 |
| Catalog Number | ULTIMATE PRO |
| Lot Number | ONE TONE 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 | 1. Required No Informationntervention | 2019-12-31 |