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

Model Number M04S

Device Problems Leak/Splash (1354); Chemical Spillage (2894); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Scarring (2061); Burn, Thermal (2530)

Event Type  Injury  

Event Description

Late yesterday evening our daughter's malem alarm malfunctioned and caused the batteries to explode.The batteries leaked from within the alarm unit and spilled all over her body.It has caused her tremendous pain and scared her as well.We had to take her to the er of the nearby hospital for treatment.This was a new alarm which was used for the first time.My daughter is only 3 years old and she has scars on her body now.Blue color.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7323073
• MDR Text Key: 101979795
• Report Number: MW5075735
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR