MAUDE Adverse Event Report: MALEM MEDICAL MALEM BEDWETTING ALARM

Device Problems Burst Container or Vessel (1074); Melted (1385); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 12/08/2016

Event Type  Injury  

Event Description

The malem bedwetting alarm i purchased overheated and exploded, causing burn marks on my son's neck.Treated these burn marks at home with a first aid kit.Checked exploded pieces and realized some parts such as the plastic on the back side of the product has melted.My (b)(6) year old suffered severe burn marks.Product was purchased from: (b)(6).Treated neck burns at home.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL; 17737 new hampshire ave.; ste 100; ashton MD 20861
• MDR Report Key: 6170331
• MDR Text Key: 62263242
• Report Number: MW5066655
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• 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: 27 YR