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

Model Number ULTIMATE PRO BEDWETTING ALARM

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problems Eye Injury (1845); Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Type  Injury  

Event Description

I am so upset that the clip broke and hit my eye.I used the alarm for the first time for my daughter and this happened.I was setting it on her underwear and i lifted the clip.It snapped right out of the sensor and hit me in the eye.I had to go to the er and have internal bleeding in my eye now.This is a defective product.I have returned it back.After breaking, the metal discs were poking out from the sensor which cut my fingers.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE PRO BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9140453
• MDR Text Key: 160882476
• Report Number: MW5090112
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE PRO BEDWETTING ALARM
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention