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

Model Number BLUE ALARM

Device Problems Device Alarm System (1012); Malposition of Device (2616)

Patient Problem Strangulation (2084)

Event Date 07/17/2019

Event Type  Injury  

Event Description

Checked on daughter first night she was using the alarm at 6:30am and she was choking with the cable wrapped around her neck.The cord is too large for her and it somehow wrapped around her neck and strangled her.Had to promptly remove sensor and alarm.No warning on product either.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CODITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8826520
• MDR Text Key: 152353449
• Report Number: MW5088366
• 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: 07/22/2019

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: Lay User/Patient
• Device Model Number: BLUE ALARM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR