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

Model Number M05

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 10/16/2018

Event Type  Injury  

Event Description

My son has been injured from using the malem alarm.I was prescribed the alarm for my son and purchased it online.The alarm does not work appropriately and gets very hot.It was worn for 30 mins and it malfunctioned and burnt my son in his neck.We gave him an anti-burn ointment and took him to the pediatrician next morning.The alarm has changed shape from heat.The housing has partially melted and thinned out from heat.

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; lowdham, nottingham ; UK
• MDR Report Key: 7990234
• MDR Text Key: 124666733
• Report Number: MW5080716
• Device Sequence Number: 0
• Product Code: KPN
• 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: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M05
• 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: 8 YR
• Patient Weight: 28