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

Model Number M04SC

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Overheating of Device (1437)

Patient Problems Irritation (1941); Burn, Thermal (2530)

Event Date 07/09/2018

Event Type  Injury  

Event Description

Parents used an enuresis alarm on their daughter and the device has malfunctioned.The enuresis alarm overheated and batteries burst within the alarm unit.This caused the batteries to leak out on the child's neck.The heat generated by the alarm was significant to bend the plastic cover and the combination of hot battery leak and burning plastic has irritated child's skin.The parents brought the girl into the clinic for treatment.The alarm has been since returned to the family.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD; lowdham, nottingham, gb NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 7689230
• MDR Text Key: 114055285
• Report Number: MW5078371
• 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
• Report Date: 07/11/2018

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: M04SC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2018
• 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: 24