MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for MALEM ALARM ULTIMATE 1 TONE PRO manufactured by Malem Medical Ltd..
[175479897]
As a pharmacist i often teach pts how to use an enuresis alarm. I purchased one for my son and it has malfunctioned. He has developed a severe skin rash from using the enuresis alarm over a period of 5 nights. The root cause of this is the heat generated by the enuresis alarm when it detects urine and starts to keep and vibrate. Otherwise, it is normal and looks fine. But once urine is detected, it gets warm. The rash is on his neck where the alarm is connected and in contact with his skin. It's a severe rash and i have discontinued use as this is not a side effect expected by using an enuresis alarm. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092232 |
| MDR Report Key | 9591555 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-11 |
| Date Added to Maude | 2020-01-15 |
| 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 | PHARMACIST |
| 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 ALARM |
| Generic Name | ALARM, CONDITIONED RESPONES ENURESIS |
| Product Code | KPN |
| Date Received | 2020-01-14 |
| Model Number | ULTIMATE |
| Catalog Number | 1 TONE PRO |
| Lot Number | MISSING |
| 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 | LOWDHAM, NOTTINGHAM UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |