MAUDE Adverse Event Report: MALEM MEDICAL LTD ULTIMATE PRO BEDWETTING ALARM BLUE 8 TONES ; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Scratched Material (3020)

Patient Problems Laceration(s) (1946); Pain (1994)

Event Date 12/08/2019

Event Type  Injury  

Event Description

Sharp edges on the clip sensor were exposed when my daughter turned over and slept on the sensor.She moves in bed and this caused the sensor to get dislodged from her clothing.Furthermore, since she was sleeping on her belly the weight likely broke the clip on the sensor exposing two sharp metal plates.When she moved again, those plates got lodged in her skin and cut her.They are sharp like a needle and cut her when was asleep.The cut is about 1.7 - 2 inches in length and very painful.We are worried that it may have caused tetanus so we got a shot from the dr.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE PRO BEDWETTING ALARM BLUE 8 TONES
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 9451445
• MDR Text Key: 170432934
• Report Number: MW5091573
• 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: 12/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR