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

Model Number PRO ULTIMATE

Device Problems Thermal Decomposition of Device (1071); Leak/Splash (1354); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

Event Description

The malem bedwetting alarm was set up and placed on the bed.I attached the sensor to the alarm.When i returned an hour later, the alarm had made a hole in the bedsheet and was fused the bedsheet.It seems that there was something that made the plastic case melt and fuse to the bedsheet.I don't know how this happened.The blue plastic had bent and partially melted.Alarm is inoperable now.The battery also leaked.Fortunately no one was operating this when it happened.My son is (b)(6) and this alarm would had caused severe and serious injuries.Burns in cloth.Fda safety report id# (b)(4).

• Brand Name: MALEM MEDICAL ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9459573
• MDR Text Key: 170663868
• Report Number: MW5091619
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PRO ULTIMATE
• Device Catalogue Number: BLUE COLOR
• 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): Other
• Patient Age: 4 YR