MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-31 for BEDWETTING ALARM manufactured by Malem Medical Ltd..
[173648870]
The bedwetting alarm has been used for several days (8 nights). Son has developed severe skin rash to the alarm. The place there the alarm is clipped is red with small blisters and the cable has also caused red marks. There is something in the alarm that is either unsafe or bad for skin. After 4 nights, i used alcohol wipes to disinfect the alarm and cord and retried, but it's not helping. Son is in pain and has to use lotion. This is not the side effect. Something wrong with the product. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091994 |
| MDR Report Key | 9540129 |
| Date Received | 2019-12-31 |
| Date of Report | 2019-12-29 |
| Date of Event | 2016-12-26 |
| Date Added to Maude | 2020-01-02 |
| 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 | BEDWETTING ALARM |
| Generic Name | ALARM, CONDITIONED RESPONSE, ENURESIS |
| Product Code | KPN |
| Date Received | 2019-12-31 |
| 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 | 2019-12-31 |