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

Model Number M-05S

Device Problems Leak/Splash (1354); Overheating of Device (1437); Electrical Shorting (2926)

Patient Problem Burn, Thermal (2530)

Event Date 12/04/2018

Event Type  Injury  

Event Description

An apparent defect in the malem bedwetting alarm has caused the alarm to overheat in the middle of the night when the user was asleep.The child using the device is a (b)(6) boy who was told to use the enuresis alarm by a medical practitioner.The child¿s parents ordered this particular model (m-05s) from the manufacturer.The new alarm was used for about 3 hours and it short circuited.The batteries short out creating extreme heat and leaking from the underside of alarm.The child was burnt in the chest area.Although the burns were minor, they should not have happened.Parents have brought child to our clinic for treatment.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; nottingham ; UK
• MDR Report Key: 8164636
• MDR Text Key: 130653085
• Report Number: MW5082128
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/11/2018

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: No Information
• Device Model Number: M-05S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 YR