MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for BEDWETTING ALARM M04S manufactured by Malem Medical Ltd..
[185696204]
Used another bedwetting alarm for my son 2 years ago but he has relapsed since and i switched to the malem alarm. The alarm started smoking once batteries were inserted and got so hot that i was worried about my safety. Had to immediately remove them with gloves as it was so dangerous to hold and operate. Changed to different and new batteries but same thing again. There is either an electrical short or some dangerous issue with the device making it unusable. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093958 |
| MDR Report Key | 9897187 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-20 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-27 |
| Model Number | M04S |
| 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 | 2020-03-27 |