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

Model Number BEDWETTING ALARM

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979)

Patient Problem Laceration(s) (1946)

Event Date 09/08/2019

Event Type  Injury  

Event Description

Alarm sensor opened up at night and cut my son in his stomach.When he moved, the sensor cut him deeper.The clip broke off first exposing the metal sharp points.This is a poor and dangerous design.The cuts are painful.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9075963
• MDR Text Key: 158996676
• Report Number: MW5089823
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BEDWETTING ALARM
• Device Catalogue Number: ULTIMATE PRO
• Device Lot Number: GOLD COLOR
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 YR