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

Model Number ULTIMATE VERSION

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Choking (2464)

Event Date 06/15/2019

Event Type  Injury  

Event Description

Cord strangled the child at night when he was sleeping.Not safe.I am fortunate to notice it when i checked on my son, he was with the cord in the night and noticed him choking.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8730911
• MDR Text Key: 149242313
• Report Number: MW5087578
• 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: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE VERSION
• Was Device Available for Evaluation?: No
• 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