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

Model Number ULTIMATE PRO ALARM

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 12/05/2019

Event Type  Injury  

Event Description

Our office treated a (b)(6) y/o child who was hurt while asleep using the malem enuresis alarm.The alarm was not used before and purchased from the mfr's website in (b)(6).The device was 2 aaa batteries to operate and a moisture sensor.The parents said that the device appeared to operate as expected and they connected it on child; 30 mins into his sleep, the child was awoken by a malfunctioning device which somehow overheated and burnt child's skin.Child was asleep and unable to remove the device on his own.Parents had to assist child.Our clinic then treated the child for minor burns.The alarm is in our possession.Fda safety report id# (b)(4).

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; lowdham, nottingham ; UK
• MDR Report Key: 9505551
• MDR Text Key: 172415607
• Report Number: MW5091804
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO ALARM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• 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: 7 YR
• Patient Weight: 26