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

Model Number M42

Device Problem Scratched Material (3020)

Patient Problem Injury (2348)

Event Date 11/01/2019

Event Type  malfunction  

Event Description

The underside of the sensor has sharp metal pins exposed.There are like sharp needles on the underside and are about 4-5 mm long.How can this be used on body.It can easily poke and cause severe injuries.I am not sure if this is a design issue or a product mfg problem.Either way, this is dangerous to use especially when a child is asleep.Imagine placing a 4-5 mm needle on your child's body when they are asleep.It's metal, sharp and thin enough to puncture skin.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: 9315684
• MDR Text Key: 166362726
• Report Number: MW5091006
• 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: 11/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M42
• Device Catalogue Number: ULTIMATE BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR