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

Model Number M04S

Device Problems Overheating of Device (1437); Material Deformation (2976)

Patient Problems Discomfort (2330); Burn, Thermal (2530)

Event Date 07/09/2018

Event Type  Injury  

Event Description

It's 9:30pm in our house and i put my son to sleep an hour ago.He came crying to us and said that his alarm was burning him.I found it hard to believe, but indeed, it was true.The alarm did burn him.It is the first time that we used this alarm.I just put in batteries and placed it on my son and he went to sleep.The back part of the alarm was so hot that it was difficult to hold it in my hand.The alarm has been deformed at the back where it clips to the shirt from heat and my son has a burn mark.It's not serious, but he needs first aid treatment which we just gave him.This alarm has a problem and is overheating.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7677467
• MDR Text Key: 113657360
• Report Number: MW5078315
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Device Catalogue Number: BLUE 1 TONE WITH VIBRATION
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR