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

Model Number M04S

Device Problems Overheating of Device (1437); Defective Component (2292); Protective Measures Problem (3015)

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

Event Date 06/06/2018

Event Type  Injury  

Event Description

I ordered a bedwetting alarm from malem medical uk and it arrived yesterday.The alarm has a mfg defect.It get very hot when batteries are placed in the alarm.This makes the device not just unusable but also dangerous for children.My son would get burnt with the device as it would be placed very close to his neck.It is unsafe, i know that this is not caused by defective batteries.I have tried over 3 different types of batteries.(b)(6) batteries, and the same result.The device gets very hot.So hot that i can't even hold it in my hands, let alone a child wear it at night.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7590785
• MDR Text Key: 110752780
• Report Number: MW5077739
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR