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

Model Number MO4S

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Melted (1385); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 12/27/2017

Event Type  Injury  

Event Description

It's about 1 am and the malem bed-wetting alarm that my daughter has strapped on has burnt her.The alarm is extremely hot and the back door that snaps in and holds batteries in place has melted from the heat.It is unfortunate that this happened.Additionally, the heat has caused the two aaa batteries inside the alarm part to burst and leak onto my daughters clothing and seep in to her neck and chest.She has had a reaction to the battery liquid and has been slightly burnt from both battery liquid and the hot bed-wetting alarm.

• Brand Name: MALEM BED-WETTING ALARM
• Type of Device: MALEM BED-WETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL (UK)
• MDR Report Key: 7156793
• MDR Text Key: 96225431
• Report Number: MW5074309
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MO4S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 22