MAUDE Adverse Event Report: MALEM MEDICAL MALEM BED-WETTING; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04

Device Problems Leak/Splash (1354); Melted (1385); Electrical Shorting (2926)

Patient Problem Burn, Thermal (2530)

Event Date 01/09/2018

Event Type  Injury  

Event Description

A medical device we are using (malem bedwetting alarm) has malfunctioned.As soon as batteries were inserted, the alarm started ticking and making a clicking noise.Within a few minutes, it started getting hot and warm that's when i noticed that there was something oddly off with the product.I immediately removed it from my son's clothing and set it on the table.Within half an hour, the alarm short circuited the batteries and caused the batteries to leak out completely.This is dangerous in my opinion and if my son were wearing this alarm, it could have easily burnt him.Since this alarm is placed close to the neck, the burns could have been very severe.The alarm was so hot that the plastic casing melted and fused to the table.

• Brand Name: MALEM BED-WETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7193552
• MDR Text Key: 97480327
• Report Number: MW5074556
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2018
• 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
• Patient Weight: 21