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

Device Problem Unintended Electrical Shock (4018)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2019

Event Type  malfunction  

Event Description

Alarm gives shock on detecting wetness.It gives shocks in his sleep.Just too bad.Fda safety report id # (b)(4).

• Brand Name: MALEM BLUE COLOR
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 9117854
• MDR Text Key: 160228141
• Report Number: MW5090010
• 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: 09/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR