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

Model Number M042

Device Problem Leak/Splash (1354)

Patient Problems Erythema (1840); Burn, Thermal (2530)

Event Date 05/14/2019

Event Type  Injury  

Event Description

Dangerous alarm.It went from room temperature to extremely hot in 20 mins.Daughter was asleep in her bed with the alarm connected on her body when the alarm developed a defect and injured her.She removed the alarm but not on time.She was burnt on bosy.Skin was red.We did not feel the need to go to the hosp for treatment, but the burns were treated at home.We discussed with her dr as well and he kept the defective alarm.By the time we removed the alarm, the batteries leaked from within the inside and spread out all over the alarm and my daughter's clothes.This could be a freak case, but it's still scary.The device is new.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8636340
• MDR Text Key: 146101674
• Report Number: MW5086850
• 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: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Device Catalogue Number: ULTIMATE ALARM
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR