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

Model Number M04S

Device Problem Use of Device Problem (1670)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/26/2017

Event Type  Injury  

Event Description

Today was the first time i used the alarm on my little girl.She is a bedwetter and i purchased a product for her so she could stop wetting the bed.It says that the product is highly effective in curing bedwetting in children of all ages.My daughter turned (b)(6) in (b)(6) this year and i put it on her when she was taking a nap.When i returned, she had swallowed the battery door that is at the back of the alarm.All this happened in just 15 minutes.She likely woke up and played with the alarm and then ate the battery door.It could have been life threatening for her if i was not there.She chocked on the battery door.It took about a minute to get it off from her.She was crying frantically.The package does not say its not for children.I wanted to bring this urgent matter to your attention.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 6750653
• MDR Text Key: 81400211
• Report Number: MW5071267
• 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: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• 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): Life Threatening; Required Intervention
• Patient Age: 2 YR