MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ALARM

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/20/2017

Event Type  Injury  

Event Description

I prescribed a malem enuresis alarm for a (b)(6) child.They purchased the product on (b)(6) and the first night of use, the enuresis alarm failed to operate correctly.The child had worn the alarm when it apparently over-heated and caused serious burns to the child.Parents contacted me at around 9:50 pm at night to address the issue.The child has suffered second degree burns from use of the enuresis alarm.I have prescribed several products to children over the years.This is the third reported case of a malem alarm over-heating in the last 5 months.The alarm is in my possession.Have discontinued prescribing this alarm for safety reasons.

• Brand Name: MALEM
• Type of Device: ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6435729
• MDR Text Key: 70980410
• Report Number: MW5068654
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 22