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

Model Number M04S

Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)

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

Event Date 05/01/2018

Event Type  Injury  

Event Description

We purchased a malem bedwetting alarm at the recommendation of a pediatrician.The first alarm had a strange problem in that it would get hot within mins of us inserting batteries into it.The alarm was hot to a point that it could not be used within an hour.We kept the alarm and tested it with different set of batteries, but the same thing happened.We returned it for another malem alarm.At first, the alarm seemed to operate fine, however, my son came about 3 hrs later complaining that he was uneasy and that the alarm was too hot and he had to remove it.We examined it closely and indeed, the same problem was with the alarm as well.It was just getting hot every time we put in batteries.The only difference was that the first alarm would get hot within mins and this one would get hot after 3-4 hrs.In either case, the alarm is too hot to hold and wear safely at night.This is a defect and not a safe product.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 7493884
• MDR Text Key: 107698926
• Report Number: MW5077027
• 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: 05/04/2018

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR