MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-29 for ENURESIS ALARM BY MALEM ULTIMATE WITH 8 TONES manufactured by Malem Medical Ltd.
| Report Number | MW5090769 |
| MDR Report Key | 9255422 |
| Date Received | 2019-10-29 |
| Date of Report | 2019-10-27 |
| Date of Event | 2019-10-22 |
| Date Added to Maude | 2019-10-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 0 |
| Brand Name | ENURESIS ALARM BY MALEM ULTIMATE WITH 8 TONES |
| Generic Name | ALARM, CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2019-10-29 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALEM MEDICAL LTD |
| Brand Name | ENURESIS ALARM BY MALEM ULTIMATE WITH 8 TONES |
| Generic Name | ALARM, CONDITIONED RESPONSE ENURESIS |
| Product Code | KPN |
| Date Received | 2019-10-29 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MALEM MEDICAL LTD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-29 |