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

Model Number MO42 - BLUE

Device Problems Break (1069); Malposition of Device (2616); Scratched Material (3020)

Patient Problems Tissue Damage (2104); Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)

Event Date 07/24/2019

Event Type  malfunction  

Event Description

The moisture sensor clip that connects to the underwear broke halfway through the night exposing rough metal plates.These plates were very sharp and when my son turned in bed, they cut him on his thigh and lodged in his skin.We had to carefully remove it and take him to the er worried that he may get tetanus.The cut was sharp and deep.There was a lot of blood on the bed.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: 8856204
• MDR Text Key: 153230941
• Report Number: MW5088665
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MO42 - BLUE
• 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): Other
• Patient Age: 5 YR