MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-31 for MALEM PRO SINGLE TONE manufactured by Malem Medical Ltd.
[173502919]
The complaint is related to the malem enuresis alarm which i have tried to unsuccessfully use on my daughter. I purchased the enuresis alarm from the manufacture? S website at the recommendation of a pediatrician. The alarm has a defect wherein it's heating up whenever my daughter wets the bed. The first night she used the alarm and she slept, she wet and woke up. She complained the alarm was warm. I reset the alarm by removing the batteries and reinserted. Seemed to work fine, but when she slept and wet again, the alarm got hot once again. The heating up of the device is not normal. The temperature is over 150f and for that reason i discontinued use. I believe the alarm can get hotter if unchecked and can cause skin damage. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091950 |
| MDR Report Key | 9538709 |
| Date Received | 2019-12-31 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-12-27 |
| 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 |
| Generic Name | ALARM, CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2019-12-31 |
| Model Number | PRO |
| Catalog Number | SINGLE TONE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALEM MEDICAL LTD |
| Manufacturer Address | GB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-31 |