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

Model Number M04S

Device Problems Leak/Splash (1354); Overheating of Device (1437); Defective Component (2292); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2018

Event Type  Injury  

Event Description

I wish to report a medical device malfunction for a product which my (b)(6) daughter was using at night.She has been bed-wetting since she was a kid and at the recommendation of a pediatrician, we purchased an (b)(4) alarm.The product did not work well so we switched brands and purchased the (b)(4) alarm.It is defective.The alarm was set up just like the other alarm was set up but what is frustrating is the amount of heat that this alarm generates.I put it on my daughter and put her to sleep.She screamed out loudly and when i went to check on her, she said that she felt the alarm was on fire.I checked and it was very, very hot like someone had burnt the alarm.I immediately removed it from her and put it aside.I helped my daughter and when we returned, i saw that the alarm had a bent back from the heat and the batteries had leaked inside the alarm and spilled all over the bed.This is rather unsafe and dangerous for a little child who is only (b)(6).Fortunately, she was not burnt but could have been if i had not reached on time.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7717702
• MDR Text Key: 115060428
• Report Number: MW5078560
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2018
• 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
• Patient Weight: 19