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

Model Number M042

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

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 08/22/2019

Event Type  Injury  

Event Description

The clip sensor broke exposing the inside metal discs during night.When my son moved, the disc hit him in the side of his stomach and got lodged there.It was not a big cut, less than half an inch in length.The issue is that the device is not unusable and dangerous to operate.With sharp metal discs poking out, they can cut skin at any time at night.Fda safety report id (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8936160
• MDR Text Key: 155938712
• Report Number: MW5089355
• Device Sequence Number: 0
• Product Code: KPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Non-Healthcare Professional
• Device Model Number: M042
• Device Catalogue Number: M042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Age: 13 YR