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

Model Number M04

Device Problems Overheating of Device (1437); Chemical Spillage (2894)

Patient Problems Rash (2033); Reaction (2414); Chemical Exposure (2570); Partial thickness (Second Degree) Burn (2694)

Event Date 11/28/2017

Event Type  Injury  

Event Description

My daughter's bedwetting alarm shorted out at night when she was asleep.The alarm got very hot and caused batteries to leak onto her body.The chemical reaction has caused severe skin rash and we had to give her first aid treatment.The red marks have become blisters and she has discontinued using the alarm.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 7078642
• MDR Text Key: 93719712
• Report Number: MW5073682
• 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: Other
• Type of Report: Initial
• Report Date: 11/30/2017

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
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 19