MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-20 for MALEM ALARM FOR BEDWETTING M04S manufactured by Malem Medical, Ltd..
[180780063]
Last night, our daughter was sleeping with her bedwetting alarm and when she wet herself, the alarm gave her a shock in her genitals. She was in excruciating pain and crying when i checked her room. The alarm does not work anymore. It discharged the batteries. This is shock therapy, not normal bedwetting alarm. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093186 |
| MDR Report Key | 9739802 |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-17 |
| Date Added to Maude | 2020-02-21 |
| 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 ALARM FOR BEDWETTING |
| Generic Name | ALARM, CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2020-02-20 |
| Model Number | M04S |
| 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 | 2020-02-20 |