MAUDE Adverse Event Report: BEDWETTING ALARM COMPANY / MALEM MEDICAL MALEM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04

Device Problems Fluid/Blood Leak (1250); Melted (1385); Overheating of Device (1437); Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 11/17/2017

Event Type  Injury  

Event Description

This is the second malem bedwetting alarm that we purchased.In the first one, as soon as inserted batteries, the alarm unit would start to get hot.I purchased it for my (b)(6) y/o daughter.Upon inserting batteries, the alarm unit got hot in 15 minutes.Tried it for 2 nights and then when the same thing happened, i set it aside and returned it for another malem model.Hoping that the first one was defective.The second one i received was worse than the first one.At first, the alarm was cool to touch with no warmth, so i placed it on my daughter as per instructions.Then just 30 minutes into her sleeping at night, she screamed out and when we turned on the lights, we found that the alarm had overheated and batteries had leaked out from the alarm unit onto her neck, chin, and hands.The battery acid has burned her on contact as it was very hot.The outer casing had melted from the heat and caused burns.Both units have problems.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): BEDWETTING ALARM COMPANY / MALEM MEDICAL
• MDR Report Key: 7052185
• MDR Text Key: 92843143
• Report Number: MW5073503
• 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: 11/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04
• 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): Other
• Patient Age: 7 YR
• Patient Weight: 29