MAUDE Adverse Event Report: MALEM MEDICAL MALEM ULTIMATE BEDWETTING ALARM

Model Number M04S

Device Problems Melted (1385); Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 07/02/2017

Event Type  Injury  

Event Description

I bought a malem bedwetting alarm on (b)(4) for my step-son.We received it on (b)(6) and used it that night.On the night of (b)(6), i connected it as per instructions on my step-son and made sure that the alarm and sensor were placed correctly as per instructions.He went to bed and at 3:30am, i went to his bed to make sure he goes and empties his bladder.I noticed there was while paste type material on his shirt and had spread to his neck.Immediately i removed the alarm and in the process burnt my finger.The alarm was very hot i woke him up and he was burnt on his neck where the alarm was placed.The alarm remained on the table side and within a few minutes, the blue color alarm started melting from the heat and we could smell burning plastic.My step-son was taken to the doctor next morning.They encouraged me to report to the fda.It has been 2 weeks now and is still has patches on his neck from the alarm.The product has been returned to (b)(4).I am frustrated that a child suffered through this because of a poor quality and inferior product.This alarm is dangerous.If i had not woken up on time, he could have been seriously hurt.The doctors have told me to discontinue this alarm and use another brand, but we are afraid of what may happen in the future.You should look into this product for its dangerous quality.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: MALEM ULTIMATE BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6717989
• MDR Text Key: 80193712
• Report Number: MW5071020
• 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: 07/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Device Catalogue Number: BLUE COLOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 6 YR