MAUDE Adverse Event Report: MALEM MEDICAL MALEM ALARM; ENURESIS ALARM

Model Number M04S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Choking (2464)

Event Date 10/31/2017

Event Type  Injury  

Event Description

I purchased a malem alarm to stop bedwetting in my(b)(6) y/o kid.We placed it on her and she went to bed, but a few minutes later, she was able to remove the battery compartment door and swallow it.The battery compartment door is very small and i am surprised that it is in a product which is for a young infant.This could be fatal.I was able to remove it on time before anything serious happened.This product is not for young children and should be mentioned on it.

• Brand Name: MALEM ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 6995728
• MDR Text Key: 90950255
• Report Number: MW5073077
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• 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: 3 YR
• Patient Weight: 15