MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM

Device Problem Melted (1385)

Patient Problem Burn, Thermal (2530)

Event Date 08/01/2017

Event Type  Injury  

Event Description

The malem alarm which i purchased from the website (b)(6), due to which the battery melted and burnt my child's neck.I had to rush my son to the hospital and he was admitted for 2 days.My (b)(6)son has suffered permanent burn marks.Why is the malem alarm still on the market? all malem alarms should be recalled immediately.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6773099
• MDR Text Key: 82127711
• Report Number: MW5071406
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• 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: 08/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 3 YR