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

Model Number M04S

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/20/2020

Event Type  Injury  

Event Description

Used another bedwetting alarm for my son 2 years ago but he has relapsed since and i switched to the malem alarm.The alarm started smoking once batteries were inserted and got so hot that i was worried about my safety.Had to immediately remove them with gloves as it was so dangerous to hold and operate.Changed to different and new batteries but same thing again.There is either an electrical short or some dangerous issue with the device making it unusable.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: 9897187
• MDR Text Key: 185696204
• Report Number: MW5093958
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M04S
• 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: 9 YR