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

Model Number ULTIMATE ALARM

Device Problem Protective Measures Problem (3015)

Patient Problems Dyspnea (1816); Choking (2464)

Event Date 07/27/2019

Event Type  Injury  

Event Description

Last night, the alarm cord wrapped around my son's neck and he was choking and gasping for breath when i helped him.This could have caused a fatal problem and loss of life.Too dangerous to use.Cord is dangerous and no indication of this highly likely and possible event.Discontinued use.Fda safety report id # (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8850138
• MDR Text Key: 153282217
• Report Number: MW5088611
• 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: 07/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE ALARM
• 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): Required Intervention
• Patient Age: 5 YR