MAUDE Adverse Event Report: MALEM MEDICAL MALEM ALARM

Model Number ULTIMATE

Device Problems Overheating of Device (1437); Fumes or Vapors (2529); Battery Problem (2885); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2017

Event Type  Injury  

Event Description

My son went to bed with his alarm.He has been wetting the bed since he was little.Now at age (b)(6), he continues to wet.This was the fourth night we used the malem alarm and it was a complete disaster.The alarm started making a strange rattling sound as soon as he put it on at night and i removed it when in heard it.As soon as i placed it on the table, it started vibrating and within a few minutes as we looked at it, the batteries started oozing out from the alarm.The case was so hot that there were fumes from it.Luckily my son is unhurt.

• Brand Name: MALEM ALARM
• Type of Device: MALEM ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6686718
• MDR Text Key: 79170458
• Report Number: MW5070801
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: ULTIMATE
• Device Catalogue Number: BLUE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR