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

Model Number M042

Device Problems Device Alarm System (1012); Leak/Splash (1354); Overheating of Device (1437); Battery Problem (2885); Electrical Shorting (2926)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 07/26/2019

Event Type  Injury  

Event Description

My son was asleep with the malem alarm (1st use night) when he woke up to a painful stinging on his skin.The malem alarm had malfunctioned and as a result short circuited during the night he was using it.The alarm was extremely hot and he as able to remove it.However in the process, while removing his shirt, the alarm hurt his cheek and the alarm burnt him on his cheeks.The cause appears to be serious because the batteries leaked and spilled outside the alarm.Too dangerous and risky.Fda safety report id # (b)(4).

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8865896
• MDR Text Key: 153523741
• Report Number: MW5088806
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M042
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 6 YR