MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for ENURESIS ALARM ULTIMATE BEDWETTING ALARM manufactured by Malem Medical Ltd..
[184812147]
My son was asleep on his first night with the bedwetting alarm. He woke up to burning plastic smell and a very hot alarm which burnt his neck and left a red patch. I contacted the company numerous times, they did not bother responding. This alarm is dangerous and very unsafe. My son is just (b)(6) and he was injured in his sleep. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093883 |
| MDR Report Key | 9865358 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-03-17 |
| Date Added to Maude | 2020-03-23 |
| 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 | ENURESIS ALARM |
| Generic Name | ALARM, CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2020-03-20 |
| Model Number | ULTIMATE BEDWETTING ALARM |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-20 |