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

Device Problems Circuit Failure (1089); Leak/Splash (1354); Overheating of Device (1437); Defective Component (2292)

Patient Problem Rash (2033)

Event Date 08/03/2018

Event Type  Injury  

Event Description

My daughter's enuresis alarm has malfunctioned.The new alarm has short circuited and caused batteries to leak onto skin causing severe skin rash.The enuresis alarm was extremely hot to touch like it was on fire from the inside.The alarm is defective.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7769668
• MDR Text Key: 116718894
• Report Number: MW5079015
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• 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): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 32