MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for BEDWETTING ALARM MALEM manufactured by Malem Medical Limited.
[185049254]
This is the second time we have had a problem with this particular brand of bedwetting alarm. We purchased a malem from (b)(6) and the moment we inserted batteries, the device got super hot. I called malem and they told me to return the alarm for a new one. After doing that, the new alarm which was a replacement for the old one is also doing the same thing. Just gets hot when batteries are inserted rendering the device completely useless and dangerous. The outside temperature easily exceeds what is normal. Too hot to operate. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093907 |
| MDR Report Key | 9877376 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-22 |
| Date of Event | 2020-03-20 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-24 |
| Model Number | MALEM |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALEM MEDICAL LIMITED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |