MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM

Device Problem Temperature Problem (3022)

Patient Problems Erythema (1840); Pain (1994)

Event Date 05/25/2017

Event Type  Injury  

Event Description

I bought malem ultimate royal blue bedwetting alarm on (b)(6) website.When i received the product, it appeared to be of extremely inferior quality.I bought it to use on my (b)(6) son.It appeared dangerous, but i still used it on him.It may sound hard to believe but after just 4 hours of use, the very first night, (i put the alarm on him at 9pm and at about 1 am) my son came running and screaming into my bedroom and told me that alarm is getting so hot that he has something hurting on his neck.I checked his neck and there was a big red patch near the place the alarm was touching his neck.Full night neither me or my son could sleep due to pain and terror he had felt.I kept on applying soothing lotion the whole night still showed him to my doctor in the morning.They recommended that i discontinue use and the doctor recommended that i contact and report the adverse event to the fda.It is unacceptable as a consumer to get something was dangerous for children.If this alarm was not removed at proper time the harm done to my child could be extremely dangerous.The government should take care of any such dangerous products sold and should be removed immediately so there should be no further harm to any child.I am expressing my personal frustration because of what we had to suffer.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: MALEM ULTIMATE BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6597864
• MDR Text Key: 76255064
• Report Number: MW5070064
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• 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: 5 YR