MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for BEDWETTING ALARM 1 TONE ALARM ULTIMATE PRO manufactured by Malem Medical Ltd..
[175227859]
Malem bedwetting alarm purchased with high hopes, but is either defective or faulty, but certainly very dangerous to use. Alarm was placed as per instructions on son while he was asleep and he complained of excess heat and burning smell 10 mins after he went to bed. I checked on it and he was right. The alarm was hot and there was bad smell coming from the alarm. I promptly removed the alarm from him/ his shirt and placed the alarm on the side. After 30 mins, the alarm was no longer hot. The batteries inside the alarm leaked and spilled on the outside of the alarm. The alarm stopped working. This could have seriously injured my son who is only 4 y/o. Fda safety report id# 492345. See scanned pages.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092216 |
| MDR Report Key | 9591236 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-12 |
| Date of Event | 2020-01-09 |
| 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 | 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 | BEDWETTING ALARM |
| Generic Name | ALARM, CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2020-01-14 |
| Model Number | 1 TONE ALARM |
| Catalog Number | ULTIMATE PRO |
| Lot Number | BLUE COLOR |
| Operator | LAY USER/PATIENT |
| 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 | 2020-01-14 |