MAUDE Adverse Event Report: MALEM MEDICAL MALEM ENURESIS ALARM

Model Number M048TEC

Device Problems Overheating of Device (1437); Defective Component (2292); Device Operates Differently Than Expected (2913)

Patient Problem Burn, Thermal (2530)

Event Date 04/17/2018

Event Type  Injury  

Event Description

A pediatrician prescribed an alarm for my (b)(6) daughter who has bedwetting.I purchased the malem alarm from the internet and it was shipped to me.The alarm is not functioning as expected.It warms up and is hot to touch within 30 mins of operation.My daughter was mildly burnt on her neck when she was wearing the alarm in bed.Needless to say, i discontinued use and have returned it back to (b)(6).The device is definitely defective and dangerous as it could burn a young child in sleep.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: MALEM ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7450220
• MDR Text Key: 106256747
• Report Number: MW5076617
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M048TEC
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR