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

Device Problems Overheating of Device (1437); Defective Component (2292)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/04/2018

Event Type  Injury  

Event Description

Parents of a (b)(6) have reported a malfunction and defect with an enuresis alarm their daughter was using.The enuresis alarm burnt the child's chest and she had to be treated for first degree burns.Alarm has been returned back to parents and child has been advised to discontinue using device and take precaution.This is the second incident we have seen in this year related to this brand of enuresis alarm where a child got burnt.In both cases, the alarm had overheated and burnt the child where it made contact with skin.

• Brand Name: MALEM MEDICAL
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL UK; lowdham, nottingham ; UK
• MDR Report Key: 7859612
• MDR Text Key: 119788934
• Report Number: MW5079659
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/06/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 12 YR
• Patient Weight: 43