MAUDE Adverse Event Report: MALEM MALEM BEDWETTING ALARM FOR CHILDREN; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M04

Device Problems Break (1069); Component Falling (1105)

Patient Problems Vomiting (2144); Choking (2464)

Event Date 08/08/2017

Event Type  Injury  

Event Description

My daughter was using the malem alarm at night and she dropped it on the floor.The battery door popped open and she accidently swallowed it.She started to choke on the battery door and i had to induce vomiting to get it out of her throat.It could have been life threatening if not intervened on time.

• Brand Name: MALEM BEDWETTING ALARM FOR CHILDREN
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 6803268
• MDR Text Key: 83148751
• Report Number: MW5071657
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 3 YR