MAUDE Adverse Event Report: MALEM MEDICAL LTD. BEDWETTING ALARM ULTIMATE WITH 8 TONES; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 12/09/2019

Event Type  Injury  

Event Description

Our alarm is getting too hot to operate normally.With batteries in sensor connected, the alarm is unusually hot to hold by hand.Can't even be touched.It is clearly unsafe on my son who is to sleep with it.Unstable, have tried to change batteries and reinsert sensor, but it's repeating the same thing.Just getting very hot.Also, smells like its plastic case is burning and on fire; gold color.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM ULTIMATE WITH 8 TONES
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9451358
• MDR Text Key: 170434582
• Report Number: MW5091571
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR