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

Model Number BLUE 1 TONE

Device Problems Break (1069); Product Quality Problem (1506); Scratched Material (3020)

Patient Problem Injury (2348)

Event Date 12/24/2019

Event Type  Injury  

Event Description

When i placed the malem bedwetting alarm sensor on my son's underwear, i lifted the clip on the sensor and then lowered it.In the process, the clip broke off and exposed two very sharp metallic points.These were sharp like needles and one of them cut my finger very deep.This is not safe and it could very well have cut my son when he was asleep as the sensor can break by simply sleeping on top of it.I am worried that the quality is very bad and the sensor breaks in just 1 use.Not reliable, faulty and hurt my son.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM BY MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9525151
• MDR Text Key: 173068189
• Report Number: MW5091903
• 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: 12/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BLUE 1 TONE
• Device Catalogue Number: ULTIMATE PRO BEDWETTING ALARM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR