MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM MEDICAL BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number MO4

Device Problem Overheating of Device (1437)

Patient Problems Burning Sensation (2146); No Code Available (3191)

Event Date 09/19/2018

Event Type  malfunction  

Event Description

My son was asleep with his enuresis alarm in bed when the alarm overheated and leaked out batteries on his clothes.The heat from the alarm has caused him to wake up in his bed and with a small burning and stinging sensation.Although not injured, he's scared that he nearly got burnt with the alarm.It was extremely hot to touch and if in contact with skin for extended period of time, would easily cause burns.He was safe with minor burns.

• Brand Name: MALEM MEDICAL BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; lowdham, nottingham ; UK
• MDR Report Key: 7901722
• MDR Text Key: 121586330
• Report Number: MW5080049
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MO4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Weight: 20