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

Model Number ULTIMATE PRO

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 09/16/2019

Event Type  Injury  

Event Description

I was placing the urine sensor on my daughter and the alarm was on her shirt.When i lifted the clip on the sensor, the clip broke.I was not using any excess force.The clip broke and i cut my finger.There are very sharp pieces of metal on the sides of the clip which got exposed and cut me.If my daughter was using this sensor at night and the clip came off, the sensor would cut her.I have a sharp, deep cut which is causing bleeding.This sensor design is flawed and dangerous to children.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9098024
• MDR Text Key: 159605538
• Report Number: MW5089919
• 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
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE PRO
• 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