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

Model Number M05S

Device Problems Overheating of Device (1437); Vibration (1674); Defective Device (2588)

Patient Problems Scarring (2061); Burn, Thermal (2530)

Event Date 03/14/2019

Event Type  Injury  

Event Description

There is an issue with the alarm we purchased for my daughter.It is not operating normally.Every time i connect the sensor, the alarm is starting to make a small vibration like there is something stuck inside and its getting hot.My daughter was asleep on her first night with the alarm and it got very hot at night and scarred her neck.She was in bed for about 30 minutes and she removed the alarm.My husband and i noticed red marks on her neck from the burns.We took her to the doctor¿s office next morning for her burn treatment.I have sent emails to the manufacturer but they have not replied back.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8465165
• MDR Text Key: 140447450
• Report Number: MW5085344
• 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: 03/25/2019

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: M05S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR