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

Model Number ULTIMATE ALARM

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2020

Event Type  Injury  

Event Description

Alarm is unreliable.Its outer temperature is too hot to place safely on my daughter.Takes 5-10 mins for the outside to get noticeably hot and unusable.Daughter had it placed on her when she was going to sleep.She removed it and told me it was hot.I changed batteries, but no change.The product is faulty indeed.Too hot to touch and sleep with.Fda safety report id# (b)(4).

• Brand Name: MALEM MEDICAL BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9591420
• MDR Text Key: 175479328
• Report Number: MW5092224
• 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: 01/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE ALARM
• Device Catalogue Number: ULTIMATE ALARM
• 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