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

Model Number NONE

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Pain (1994)

Event Date 03/31/2018

Event Type  Injury  

Event Description

The malem alarm i purchased from the bedwetting store has burnt out completely and hurt my child.He had to be rushed to the hospital for treatment.I have noticed similar complaints online and only request that the fda look into this matter asap.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM CONDITIONED RESPONSE
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7395264
• MDR Text Key: 104415065
• Report Number: MW5076277
• Device Sequence Number: 0
• 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: 03/31/2018

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: NONE
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 39 MO