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

Device Problem Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 09/14/2018

Event Type  Injury  

Event Description

Reporting two instances where children were burned and skin scarred by the malfunction of an enuresis alarm.In both cases, the alarm was new and the children were under age 5.Both children were using new alarms purchased off an internet store in brand new condition.The burning on the skin has the children worried and confused.They have discontinued use of the alarm.Our clinic treated both children.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7901670
• MDR Text Key: 121582495
• Report Number: MW5080048
• Device Sequence Number: 2
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 09/20/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Weight: 23