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

Model Number 04SC

Device Problems Leak/Splash (1354); Overheating of Device (1437); Electrical Shorting (2926)

Patient Problem No Code Available (3191)

Event Date 12/26/2018

Event Type  Injury  

Event Description

Received by mail a new malem alarm for curing bedwetting.Inserted batteries and sensor as indicated in the user manual and set it aside.When returned after an hour, alarm had malfunctioned.Batteries had short circuited within the alarm and leaked out.Back casing bent inwards and alarm was extremely hot.Could not hold in hand, it was that hot.Fortunately child was not wearing alarm at the time of incident.

• Brand Name: ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8208571
• MDR Text Key: 131981898
• Report Number: MW5082734
• 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: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 04SC
• Device Catalogue Number: MALEM
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR