MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM PRO; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number ULTIMATE PRO ALARM

Device Problems Device Alarm System (1012); Device Emits Odor (1425); Overheating of Device (1437); Defective Component (2292)

Patient Problem Burn, Thermal (2530)

Event Date 07/16/2019

Event Type  Injury  

Event Description

After 1 night of use, the alarm is not working anymore.The first night it seemed to work fine, though there was some heat on the back of the alarm.But today the alarm is not operating at all.Followed instructions and the alarm is smelling like it's burning.The alarm is also too hot to operate and can't be used.I have changed batteries several times, but this issue is not getting resolved.The defect is in the alarm, not the way we are operating it.Skin burns.Fda safety report id# (b)(4).

• Brand Name: MALEM PRO
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8847396
• MDR Text Key: 153221631
• Report Number: MW5088572
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO ALARM
• 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): Other; Required Intervention
• Patient Age: 5 YR