MAUDE Adverse Event Report: MALEM MEDICAL UK MALEM BED-WETTING ALARM

Model Number NONE

Device Problem Overheating of Device (1437)

Patient Problems Tissue Damage (2104); Burn, Thermal (2530)

Event Date 09/10/2016

Event Type  Injury  

Event Description

My son was using the alarm at night and he came into my room screaming.I noticed that the alarm was connected on his t-shirt head overheated and burnt a hole through shirt and that scarred on his chest.

• Brand Name: MALEM BED-WETTING ALARM
• Type of Device: MALEM BED-WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL UK; UK
• MDR Report Key: 5949079
• MDR Text Key: 54793020
• Report Number: MW5064724
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NONE
• Device Catalogue Number: NONE
• Device Lot Number: NONE

Other Device ID Number

• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR