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

Model Number M04

Device Problems Overheating of Device (1437); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2018

Event Type  Injury  

Event Description

Just received the malem alarm which was ordered from (b)(6).The alarm comes with batteries.When inserted, the batteries heat up the alarm and it gets hotter and hotter.In 30 minutes, the back side of the alarm is so hot that it feels like i am touching a furnace.I don't expect to use this on my son.It is defective or faulty in design.This is not a battery issue because i have replaced the batteries with another 2 pairs and same thing happens every time.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 7334098
• MDR Text Key: 102321655
• Report Number: MW5075808
• 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: 03/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR