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

Model Number M04S

Device Problems Overheating of Device (1437); Vibration (1674)

Patient Problem No Code Available (3191)

Event Date 11/06/2018

Event Type  Injury  

Event Description

There is something not right with the bed-wetting alarm that we purchased.It is a malem brand and was purchased at the recommendation of a pediatrician.The alarm is heating up when the sensor is connected.The back casing of the alarm is hot and not touchable.It was received 4 nights ago and has never functioned correctly.When the sensor is connected, even with the latch up, the alarm is vibrating and getting hot.I let it sit for 30 mins and it was extremely hot and i could not even touch it.Surely some mechanical or electrical problem.How is a child expected to wear such a product and sleep at night?.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE
• Manufacturer (Section D): MALEM MEDICAL LTD. ; UK
• MDR Report Key: 8069400
• MDR Text Key: 127237205
• Report Number: MW5081205
• 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: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M04S
• Device Catalogue Number: MAGENTA
• 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: 8 YR