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

Model Number M04

Device Problems Radiation Leak (1357); Overheating of Device (1437); Loss of Power (1475)

Patient Problems Burn, Thermal (2530); Superficial (First Degree) Burn (2685)

Event Date 06/11/2018

Event Type  Injury  

Event Description

Enuresis alarm failure during normal operation has resulted in child getting burnt on neck area.The enuresis alarm was operated normally however the problem is within the device.The alarm has malfunctioned and overheated, causing the batteries to short out and leak.A combination of battery leak and burns has hurt the child causing first degree burns.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD.; lowdham, nottingham, gb G14 7 EJ; UK G14 7EJ
• MDR Report Key: 7605107
• MDR Text Key: 111339866
• Report Number: MW5077865
• 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: Pharmacist
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04
• Device Catalogue Number: M04S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• 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: 4 YR
• Patient Weight: 18