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

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problems Caustic/Chemical Burns (2549); Chemical Exposure (2570); Partial thickness (Second Degree) Burn (2694)

Event Date 09/27/2017

Event Type  Injury  

Event Description

I just took my son to the hospital.The batteries from this bedwetting alarm leaked out and burned his hands and chest.He has blisters all over his body and skin.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE, ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 6903560
• MDR Text Key: 87857389
• Report Number: MW5072522
• 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: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 7 YR