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

Model Number M04S

Device Problems False Alarm (1013); Overheating of Device (1437)

Patient Problems Emotional Changes (1831); Fatigue (1849)

Event Date 03/19/2019

Event Type  Injury  

Event Description

Bought this and it worked one time.After that it would go off in the middle of the night when my daughter wasn't even wet.It would also start getting very hot when the sensor was clamped on my daughter's underwear.We tested it and it didn't go off with water, but would get hot even while it was sitting on the counter.After much frustration from a tired (b)(6) year old getting scared and us worried for her safety, we returned this alarm after 3 days.How can this be used safely on any child if it is getting this hot.

• Brand Name: BEDWETTING ALARM (ULTIMATE MODEL)
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8479706
• MDR Text Key: 140945747
• Report Number: MW5085554
• 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: 03/29/2019

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: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2019
• 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