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

Model Number M04

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 01/15/2019

Event Type  malfunction  

Event Description

This is the third alarm that has had the exact same issue.We purchased a bed wetting alarm and it has malfunctioned.It gets extremely hot when the alarm starts.Takes about 20 mins and it's untouchable.We complained to the mfr and they sent us a replacement which did the same thing.Finally, we received a third alarm and that too is doing this.Too risky to use on anyone, let alone a child who is sleeping at night.Outright dangerous.

• Brand Name: ALARMS FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8270811
• MDR Text Key: 134019090
• Report Number: MW5083289
• 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: 01/17/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M04
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1