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

Model Number ULTIMATE

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 07/05/2019

Event Type  Injury  

Event Description

My 2 sons had bedwetting problems and for both i used the malem alarm.Both used the alarm on the 5th of the month.One son did not wet the bed, the other who wet the bed complained of a shock in his sleep on his penis when he had a bedwetting incident.This seemed strange and odd, but i told him he was frightened in his sleep and reattached the alarm to him after changing him to dry clothes.He again had a bedwetting incident after 4 hours and was scared as he said he got a shock once again.I was unsure and just put the sensor in a glass of warm salt water.When i put my fingers in, i felt a shock as well.This alarm is giving shocks to the place it is attached once it detects urine.Dangerous and scary to use.It has to be a critical design flaw in the alarm.I have discontinued using both alarms.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; lowdham, nottingham ; UK
• MDR Report Key: 8776292
• MDR Text Key: 150806211
• Report Number: MW5087975
• 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: Dentist
• Type of Report: Initial
• Report Date: 07/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE
• Device Catalogue Number: BLUE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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