MAUDE Adverse Event Report: MALEM MALEM

Model Number M04

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2018

Event Type  malfunction  

Event Description

Son's bedwetting alarm failed at night when he was using it.It got very hot and he took it off from his collar.The alarm burst and leaked onto his bed.Fortunately he was not wearing it at the time.The alarm has a failure i think.The leak stained the bedsheet and made a hole through it.

• Brand Name: MALEM
• Type of Device: MALEM
• Manufacturer (Section D): MALEM
• MDR Report Key: 7273120
• MDR Text Key: 100246448
• Report Number: MW5075252
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR