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

Model Number M04S

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 02/17/2020

Event Type  Injury  

Event Description

Last night, our daughter was sleeping with her bedwetting alarm and when she wet herself, the alarm gave her a shock in her genitals.She was in excruciating pain and crying when i checked her room.The alarm does not work anymore.It discharged the batteries.This is shock therapy, not normal bedwetting alarm.Fda safety report id # (b)(4).

• Brand Name: MALEM ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 9739802
• MDR Text Key: 180780063
• Report Number: MW5093186
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 5 YR