MAUDE Adverse Event Report: MALEM MEDICAL AND UBIQUITTY MALEM MEDICAL ALARM

Device Problems Defective Alarm (1014); Leak/Splash (1354); Overheating of Device (1437)

Patient Problem No Code Available (3191)

Event Date 10/11/2017

Event Type  Injury  

Event Description

I am writing this complain with regards to a bedwetting alarm that was prescribed by my daughter's pediatrician.The pediatrist told us to get a bedwetting alarm to treat her bedwetting.I purchased one from the (b)(6).It arrived in new sealed condition.The user instructions were not clear, but the online videos described the set up of the sensor and the alarm.I set it up on her exactly as explained in the videos.This was the first time that she was using the alarm.To my disappointment, the alarm has some very serious problems.The clip on the back of the alarm was pinched my daughter's finger as we inserted it on her t shirt top.This is not safe for a child to use.The bigger is the alarm itself.Within just 30 minutes of use, my daughter complained that the alarm was getting warm.I removed it from her and felt it getting warm too.It was as hot as a cell phone which is charging.I removed the batteries and let it cool down.But then when i reinserted the batteries, 20 mins later, it started getting hot again.This time i did not place it on my daughter but let it sit on the bed.An hour later, when i returned, i noticed that the alarm had leaked batteries on to the bed.The bed had gray patches on it.This was from the alarm failure.I am glad that the alarm was not on my daughter when this happened or it could have been very serious.This product failed the very first night.

• Brand Name: MALEM MEDICAL ALARM
• Type of Device: MALEM MEDICAL ALARM
• Manufacturer (Section D): MALEM MEDICAL AND UBIQUITTY
• MDR Report Key: 6954239
• MDR Text Key: 89584283
• Report Number: MW5072768
• 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
• Type of Report: Initial
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Weight: 37