MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ALARMS FOR BEDWETTING; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number ULTIMATE 8 TONE

Device Problems Overheating of Device (1437); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2020

Event Type  Injury  

Event Description

Malem alarm is unreliable.Goes off when not wet and disturbs sleep.When it goes off, the alarm is getting hot.Need to remove the batteries to let it cool down.Dangerous and unreliable.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARMS FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9785697
• MDR Text Key: 182222798
• Report Number: MW5093492
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE 8 TONE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR