MAUDE Adverse Event Report: MALEM MEDICAL, LTD. MALEM BED-WETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number MO48TEC

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 04/14/2018

Event Type  Injury  

Event Description

Our daughter's bed-wetting alarm has a severe defect.Somehow the batteries got extremely warm when it gets inserted into the device.My daughter was wearing the device at night and sleeping and i checked that the alarm was very hot.I removed it from her neck and saw that the batteries had leaked on to her clothing and body.The device was super hot and it had left a small red patch on my daughter's neck.

• Brand Name: MALEM BED-WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD. ; UK
• MDR Report Key: 7471880
• MDR Text Key: 106896603
• Report Number: MW5076816
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MO48TEC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Weight: 22