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

Model Number NONE ON THE BOX OR DEVICE.

Device Problem Overheating of Device (1437)

Patient Problems Erythema (1840); Pain (1994)

Event Type  Injury  

Event Description

I wanted to solve my (b)(6) son's bedwetting issue so after searching for some kind of treatment i came across with an advertisement from (b)(6), who sells bedwetting alarms for children and mentions that they can cure bedwetting.I ordered the blue color malem bedwetting alarm from their site which they claim is the best.After getting the alarm i read the instructions and made my son wear it at night.After about 4 hours past midnight my son screamed and shouted and told me to come to his room.I ran quickly and found that the alarm was extremely hot and where it was touching his neck he had a huge red patch.He was crying loudly and was in terrible pain.Full night i had to apply lotions and an ice pack till i took him to the doctor.I called up (b)(6) with no response from their side even after leaving multiple voicemails.I don't know how our country can allow such a harmful product from reaching here.It is an extremely dangerous product for children.If i had not removed the alarm at the right time, i don't know how much more harm my son would have had to go through.As for the safety of children, a proper action should be taken.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6543777
• MDR Text Key: 74543752
• Report Number: MW5069566
• Device Sequence Number: 1
• Product Code: KPN
• 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: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NONE ON THE BOX OR DEVICE.
• Device Catalogue Number: NONE ON THE BOX OR DEVICE.
• Device Lot Number: NONE ON THE BOX OR DEVICE.
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR