MAUDE Adverse Event Report: MALEM MEDICAL MALEM; ENURESIS ALARM

Device Problems Overheating of Device (1437); Product Quality Problem (1506)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

No good, absolutely useless and harmful children product is this malem bedwetting alarm.This alarm has low quality parts that makes alarm to get hot that is not good for the use of children.My baby was hurt.This product should not be sold.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL ; UK
• MDR Report Key: 7424836
• MDR Text Key: 105373944
• Report Number: MW5076426
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR