MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for MALEM ULTIMATE BEDWETTING ALARM MO48TEC manufactured by Malem Medical, Ltd..
[181331318]
Reporting adverse effect with the use of a malem bedwetting alarm. The alarm was used first time last night and it has malfunctioned. It overheated and burnt my son? S skin where it was in contact. Although minor, the burns were scary and we are worried. Alarm batteries leaked from the underside and alarm itself smelled strange. Non-operational now. Son has red mark on skin from the burning alarm. Skin burns. Fda safety report id # (b)(4). Fda received date: 02/21/2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093269 |
| MDR Report Key | 9753347 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-20 |
| Date Added to Maude | 2020-02-26 |
| 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 ULTIMATE BEDWETTING ALARM |
| Generic Name | ALARM, CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2020-02-25 |
| Model Number | MO48TEC |
| 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. Other | 2020-02-25 |