MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for BEDWETTING DEVICE ULTIMATE ALARM 8 TONES - SELECTABLE manufactured by Malem Medical, Ltd..
[175092761]
The bedwetting device is defective. It's unstable and gets hot when the sensor is inserted inside it. I replaced the batteries too, but that didn't help. With batteries inserted, the device is on and heats up a little bit on the outside. However, when the sensor is inserted (lever up or down, doesn't matter), the device external temperature rises rapidly till it goes from warm to hot. As i was holding it in my hand, i felt it heat up and got very hot. Not safe to operate or hold. I retried the next night with fresh batteries, but the same thing happened; 4 sets of batteries can't be faulty. Defect is in the device. Just unsafe. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092164 |
| MDR Report Key | 9580861 |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-09 |
| Date of Event | 2020-01-06 |
| Date Added to Maude | 2020-01-13 |
| 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 DEVICE |
| Generic Name | ALARM, CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2020-01-10 |
| Model Number | ULTIMATE ALARM |
| Catalog Number | 8 TONES - SELECTABLE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALEM MEDICAL, LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |