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

Model Number ULTIMATE PRO ALARM FOR BEDWETTING

Device Problem Break (1069)

Patient Problems Needle Stick/Puncture (2462); Blood Loss (2597)

Event Date 11/26/2019

Event Type  Injury  

Event Description

Last night my son was sleeping and was using the malem bedwetting alarm.Dr has said it was needed to stop nighttime bedwetting.He slept and moved as most children do.This caused the wires on the sensor to break apart from the joint and poked my son in his stomach.The wires were literally lodged in his stomach like two needles.He cried.Fortunately, the wires were not in deep.I was able to promptly remove them.This is absurd that my sleeping son should have to wake up needle piercings.There was some little amount of blood on his shirt.I contacted the mfr but i did not get any response to my phone call or email.Terrible product and service.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM FOR BOYS
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9396664
• MDR Text Key: 168787979
• Report Number: MW5091372
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO ALARM FOR BEDWETTING
• 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): Other
• Patient Age: 6 YR