MAUDE Adverse Event Report: MALEM MEDICAL UK MALEM BEDWETTING ALARM

Device Problems Burst Container or Vessel (1074); Melted (1385); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 11/30/2016

Event Type  Injury  

Event Description

I bought a (b)(6) alarm also called an enuresis alarm from the bedwetting store.At night when my son had the alarm clipped to his shirt.It overheated and exploded.My son was rushed to the doctor in the middle of the night.Till date he faces severe burn marks on his neck and doctors visits are ongoing.Product purchased: (b)(6) alarm.Problems: overheated to such degree that the battery door melted, then exploded.(b)(6).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL UK
• MDR Report Key: 6157600
• MDR Text Key: 61894907
• Report Number: MW5066589
• Device Sequence Number: 1
• Product Code: KPN
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 YR