MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ULTIMATE BEDWETTING ALARM

Device Problems Leak/Splash (1354); Overheating of Device (1437); Noise, Audible (3273)

Patient Problem Erythema (1840)

Event Type  Injury  

Event Description

I purchased the malem alarm in gold color with 8 random tones from (b)(6).The alarm was shipped discreetly and when it arrived, things worked well for the first two weeks.My son woke up to the alarm and one night, as i was putting the alarm on him, the alarm started clicking and hissing.It did that for 4-5 seconds and stopped.I put the alarm and he went to sleep.In the middle of the night, my son woke up crying and came to my room.He has a small red patch on his chest where the alarm was clipped.I found the alarm and noticed that the back of the alarm which houses the batteries had overheated and the batteries had leaked.We used neosporin and took him to the doctor next morning.The company was informed of the incident and they are not followed up since.

• Brand Name: MALEM
• Type of Device: ULTIMATE BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL; lowdham, nottingham, gb NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 6492975
• MDR Text Key: 72917521
• Report Number: MW5069074
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 1