MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ENURESIS ALARM

Model Number M04SC

Device Problem Leak/Splash (1354)

Patient Problems Erythema (1840); Swelling (2091); Burn, Thermal (2530)

Event Date 03/13/2018

Event Type  Injury  

Event Description

A brand new malem alarm which we purchased has malfunctioned a week ago.The alarm was set up just as explained and we had set it up correctly.My son was asleep when he cried and we saw that the alarm part has malfunctioned and the batteries had leaked onto his clothing.He has suffered minor burns from the hot alarm part on his neck which was in contact with his body.We administered first aid treatment with saline rinse, and he has small blisters and red patches on his body from the burn.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL ; UK
• MDR Report Key: 7365069
• MDR Text Key: 103346874
• Report Number: MW5075983
• 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: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04SC
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR