MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-07 for MALEM BEDWETTING ALARM 1 TONE ULTIMATE PRO ALARM manufactured by Malem Medicalltd..
[174293159]
Our office has loaned out a new malem bedwetting alarm to pt suffering from primary nocturnal enuresis. Pt has used the alarm for 1 night and complained that alarm has caused significant injuries to child. The alarm has overheated at night when child was sleeping and injured her by causing skin burns where alarm was touching skin. I have requested parents to return alarm, but they have disposed it off. Pt's mother also complained that alarm was emitting fouls / burning smell when they discovered the incident. Pt is traumatized and worried. They have not returned to us for treatment so we can't determine how severe the incident is. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092089 |
| MDR Report Key | 9564314 |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-04 |
| Date of Event | 2020-01-02 |
| 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 | PHYSICIAN ASSISTANT |
| 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 BEDWETTING ALARM 1 TONE ULTIMATE PRO ALARM |
| Generic Name | ALARM, CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2020-01-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALEM MEDICALLTD. |
| Manufacturer Address | LOWDHAM, NOTTINGHAM UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-07 |