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

Model Number M05

Device Problems Overheating of Device (1437); Vibration (1674); Defective Component (2292)

Patient Problem No Code Available (3191)

Event Date 12/22/2018

Event Type  Injury  

Event Description

Just received a new malem alarm from (b)(6) and the alarm is defective.It is vibrating when i place batteries and when i put the sensor inside, its warming up like a hot iron rod.To think that this would be used by my daughter in her sleep is dangerous, i have replaced 3 different sets of batteries and concluded that the issue is the alarm itself.This is an electrical defect causing it to overheat.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8199604
• MDR Text Key: 131646078
• Report Number: MW5082618
• 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: 12/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR