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

Model Number MALEM ULTIMATE PRO

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 08/12/2019

Event Type  Injury  

Event Description

The clip part on the back of the device snapped right out and my child thought it is a toy and swallowed it.Had to insert fingers in his mouth to get it out.Poor design, the small clip could get lodged in his neck and choke him if i did not reach on time.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: 8907397
• MDR Text Key: 155006794
• Report Number: MW5089148
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MALEM 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 Outcome(s): Required Intervention