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

Model Number ULTIMATE

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Code Available (3191)

Event Date 07/20/2019

Event Type  Injury  

Event Description

My (b)(6) daughter was sleeping with her bedwetting alarm and she was likely playing with the switch.The lever broke and the part fell over.She swallowed the same and i quickly noticed it and took it out of her mouth.I noticed that the lever is easy to remove and can be swallowed making it not suitable for my daughter and risky.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: 8838444
• MDR Text Key: 152753545
• Report Number: MW5088448
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ULTIMATE
• 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