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

Model Number M05

Device Problem Overheating of Device (1437)

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

Event Date 01/16/2019

Event Type  Injury  

Event Description

Our daughter has suffered an injury by using the malem bedwetting alarm.Instructions were followed exactly and the first night, the device has malfunctioned causing excess heat to dissipate from the back side of the device.This has caused my little girl to suffer pain in her neck from the burns.A red line on her neck from the burns.We removed the device and treated her at home.Next morning we visited the dr who recommended reporting the incident online.New device prescribed from the mfr and arrived in brand new condition.

• Brand Name: ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8270799
• MDR Text Key: 133961659
• Report Number: MW5083287
• 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: 01/17/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR