MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-07 for BEDWETTING ALARM ULTIMATE PRO 1 TONE ULTIMATE ALARM manufactured by Malem Medical Ltd..
[174292965]
Our bedwetting alarm was purchased in a new condition from (b)(6) website. The first night alarm was operating and worked correctly, although it did not detect urine. My daughter wet herself three times at night and the alarm did not alert even once. The next morning i changed the batteries and in the night, set it up again. When i connected the sensor and set it up, my daughter said she smell burning smell from the alarm. I removed it and smelled it. It was indeed a burning smell. As i held it, i also noticed that the alarm was hotter than normal. I waited for a few mins and the smell became worse and the temperature on the alarm rose very high. At the time, for my safety and my daughter's safety, i immediately removed the batteries and disposed off the device for fear of it setting of a fire. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092090 |
| MDR Report Key | 9564322 |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-05 |
| Date of Event | 2020-01-04 |
| Date Added to Maude | 2020-01-08 |
| 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 | CONDITIONED, ALARM, ENURESIS RESPONSE |
| Product Code | KPN |
| Date Received | 2020-01-07 |
| Model Number | ULTIMATE PRO |
| Catalog Number | 1 TONE ULTIMATE ALARM |
| Device Availability | N |
| 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. Other | 2020-01-07 |