MAUDE Adverse Event Report: MALEM MEDICAL LIMITED MALEM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number MALEM ULTIMATE BEDWETTING ALARM

Device Problems Overheating of Device (1437); Defective Device (2588)

Patient Problem Burning Sensation (2146)

Event Date 06/26/2018

Event Type  Injury  

Event Description

Alarm is getting very hot when my daughter is using it.We put in on er and she is complaining of stinging and burning sensation.I checked the alarm and indeed it is very hot.It is defective and can pose safety hazard for my daughter.Blue color.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LIMITED
• MDR Report Key: 7650172
• MDR Text Key: 112853023
• Report Number: MW5078140
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MALEM ULTIMATE BEDWETTING ALARM
• Device Catalogue Number: SINGLE BONE
• 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: 4 YR