MAUDE Adverse Event Report: MALEM MALEM ALARM

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problems Caustic/Chemical Burns (2549); Partial thickness (Second Degree) Burn (2694)

Event Date 09/13/2017

Event Type  Injury  

Event Description

Pediatrician recommended a bedwetting alarm for my son.I purchased a malem alarm from (b)(6).It was set up correctly and the third night, the alarm malfunctioned.The batteries leaked on to my son's neck and caused severe chemical burns.He had black and gray matter all over his neck and it lead to blisters.He had to be taken to the hospital for treatment.

• Brand Name: MALEM ALARM
• Type of Device: MALEM ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6875903
• MDR Text Key: 86632057
• Report Number: MW5072198
• 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: 09/15/2017

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 6 YR