MAUDE Adverse Event Report: MALEM MEDICAL UK BEDWETTING ALARM

Model Number M04S

Device Problems Radiation Leak (1357); Overheating of Device (1437); Device Operates Differently Than Expected (2913)

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

Event Date 12/21/2017

Event Type  Injury  

Event Description

This complaint is for a malem bedwetting alarm which i purchased from (b)(6).The product has a serious problem and has hurt my daughter at night.The product was set up as per the user manual and placed on her.Within a few minutes, the product got very hot.I removed batteries and let it sit.Then again, put back batteries and same thing repeated.I did not put it on my daughter that night but placed it the next night.Once again it was getting hot, so i put it on the side of her bed.About 25 minutes later, when i checked on her, the batteries had leaked onto the bed and the black leak was very hot.If this had spilled on my child's body, it would be a disaster.I am very disappointed.This product was using new batteries and somehow it leaked and got so hot.

• Brand Name: BEDWETTING ALARM
• Type of Device: BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL UK
• MDR Report Key: 7154326
• MDR Text Key: 96127896
• Report Number: MW5074272
• 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: Other
• Type of Report: Initial
• Report Date: 12/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• 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: 5 YR