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

Model Number M042

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

Patient Problems Injury (2348); Burn, Thermal (2530)

Event Date 10/16/2019

Event Type  Injury  

Event Description

The malem alarm was purchased new and used 1 night.The only night it was used, the alarm got hot and injured my daughter.She was asleep and she screamed in pain.The alarm burnt her from excess heat on her neck.Very bad product.Too dangerous.We took her to the hosp and they told us to immediately discontinue using the product.Also, they kept the alarm.It had a bad odor from it as well; like it was on fire.Daughter has small blisters on neck area now as a result of this incident.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 9225117
• MDR Text Key: 163703574
• Report Number: MW5090574
• 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: 10/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR