MAUDE Adverse Event Report: MALEM MALEM; ENURESIS ALARM

Device Problems Leak/Splash (1354); Vibration (1674); Chemical Spillage (2894); Temperature Problem (3022); Noise, Audible (3273)

Patient Problems Erythema (1840); Chemical Exposure (2570); Partial thickness (Second Degree) Burn (2694)

Event Date 09/27/2017

Event Type  Injury  

Event Description

My husband purchased a brand new malem bedwetting alarm from (b)(6).It was shipped to us and arrived a few days ago.We purchased this alarm with high expectations and started using it 2 nights ago.Once the batteries are inserted into the alarm, the alarm started to vibrate violently for 1-2 minutes and then stopped.There was a clicking sound that continues like a clock ticking.The first night, the alarm unit operated fine and my daughter did not wet the bed, but complained of the alarm getting warm.That seemed strange, but we accepted it as a possible device operation.The second night, the alarm once again continued clicking so we removed the batteries and reinserted them into the alarm unit.This time, the alarm again started vibrating for 1-2 minutes and then stopped but continued the clicking sound.I put it on my daughter at 8:45 pm and left her room.At 9:40, when i went to check the alarm, i saw that the batteries had leaked from the alarm unit and there was battery acid all over her clothing.There was battery acid on her neck as well.I immediately woke her up and quickly told her to take a shower to rinse off the battery acid.In the morning, she had an adverse effect with the battery leak.She has big red blisters on her neck now.I have taken her to a pediatrician who told me to report this incident to the fda.The battery leak if not checked could have been fatal had she reacted seriously to it.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6910657
• MDR Text Key: 88133262
• Report Number: MW5072557
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 7 YR