MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-02 for BEDWETTING ALARM ULTIMATE PRO BEDWETTING ALARM SINGLE TONE ALARM manufactured by Malem Medical Ltd..
[173742646]
The alarm did not work as described for the first night. The reset button jammed (got stuck in the casing and would not pop back out). The device then got too hot to operate and i had to remove batteries. I had to get out of the reset button with the use of a small screwdriver to dislodge. Now, when i am trying to use, the alarm, it is heating up. My son wears it and says that he is burning with it as it is hot. As such, we cannot use the device, after one night i would not expect this kind of mfg problem and unreliability in a medical device. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092014 |
| MDR Report Key | 9543512 |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-31 |
| Date of Event | 2019-12-30 |
| Date Added to Maude | 2020-01-03 |
| 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 | 2020-01-02 |
| Model Number | ULTIMATE PRO BEDWETTING ALARM |
| Catalog Number | SINGLE TONE ALARM |
| 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 | 2020-01-02 |