MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for MALEM MEDICAL BEDWETTING ALARM ULTIMATE ALARM manufactured by Malem Medical Ltd..
[175479328]
Alarm is unreliable. Its outer temperature is too hot to place safely on my daughter. Takes 5-10 mins for the outside to get noticeably hot and unusable. Daughter had it placed on her when she was going to sleep. She removed it and told me it was hot. I changed batteries, but no change. The product is faulty indeed. Too hot to touch and sleep with. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092224 |
| MDR Report Key | 9591420 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-11 |
| Date of Event | 2020-01-08 |
| Date Added to Maude | 2020-01-15 |
| 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 | MALEM MEDICAL BEDWETTING ALARM |
| Generic Name | ALARM, CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2020-01-14 |
| Model Number | ULTIMATE ALARM |
| Catalog Number | ULTIMATE 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 | 2020-01-14 |