MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for MALEM BEDWETTING ALARM 1 TONE DEVICE ULTIMATE PRO ALARM manufactured by Malem Medical Ltd..
[175650886]
Last night, while removing the bedwetting alarm sensor from my daughter's underwear, the lever on the sensor came loss and fell off. There was a sharp metal point which was protruding from the tip. It lodged in her underwear and cut her on the inner thigh. It was sharp like a knife and she was bleeding. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092292 |
| MDR Report Key | 9596190 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-13 |
| Date of Event | 2020-01-12 |
| Date Added to Maude | 2020-01-16 |
| 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 BEDWETTING ALARM |
| Generic Name | ALARM, CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2020-01-15 |
| Model Number | 1 TONE DEVICE |
| Catalog Number | ULTIMATE PRO ALARM |
| 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 | 2020-01-15 |