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

Model Number M04

Device Problems Leak/Splash (1354); Overheating of Device (1437)

Patient Problems Scar Tissue (2060); Burn, Thermal (2530)

Event Date 06/03/2018

Event Type  Injury  

Event Description

I regret purchasing this medical device.It malfunctioned within just an hour of setting it up on my son.The alarm overheated and batteries leaked out from the back casing of the device.It burnt my son in his neck and also started his clothing.My boy has blisters on his neck from the burns.I rinsed him off but the big red scars are still on his neck even after 2 days and are only getting worse.The adverse reaction to heat and leaking battery fluid has made him scared of using a bedwetting alarm again.

• Brand Name: MALEM MEDICAL BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; UK
• MDR Report Key: 7582033
• MDR Text Key: 110583717
• Report Number: MW5077681
• 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: Physician
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04
• 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: 6 YR
• Patient Weight: 26