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

Model Number ULTIMATE PRO

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Laceration(s) (1946); Blood Loss (2597)

Event Date 10/01/2019

Event Type  Injury  

Event Description

Sensor flap opened and the metal disc inside lodged out and penetrated my son's skin.It cut a 2 inch line in his stomach.Very shallow but there was bleeding.This is a design issue.Bad product and very unsafe.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 9166362
• MDR Text Key: 161601212
• Report Number: MW5090249
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR