MAUDE Adverse Event Report: MALEM MALEM BED WETTING DEVICE

Device Problem Insufficient Information (3190)

Patient Problem Choking (2464)

Event Date 10/12/2017

Event Type  Injury  

Event Description

I have a (b)(6) old son for whom i got this product.The intent was to cure his bedwetting.I have used it for 2 nights but on the third night, my son swallowed the battery door.This is a little part that is easily removable by the child and is small enough to cause a choking hazard.My son easily removed the same night and put it in his mouth.We were sleeping on the same bed and he was coughing and choking.We were able to put our finger in his mouth and removed the battery door.A highly unpleasant experience.The alarm is marketed to children at (b)(6), but the parts are so small they can easily choke a child.

• Brand Name: MALEM BED WETTING DEVICE
• Type of Device: MALEM BED WETTING DEVICE
• Manufacturer (Section D): MALEM
• MDR Report Key: 6954240
• MDR Text Key: 89595994
• Report Number: MW5072769
• 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: 10/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Weight: 13