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

Model Number MALEM

Device Problems Break (1069); Scratched Material (3020)

Patient Problems Pain (1994); Skin Tears (2516)

Event Date 09/09/2019

Event Type  Injury  

Event Description

I am so upset that the clip broke and sharp metals in the sensor has cut my son's skin.Why would this company sell such a defective product, with so many complaints with the clip breaking.I am not the only one with this issue.This is really very dangerous.The metal plates in the sensor are very sharp and there was a lot of blood on my son's bed when he woke up in pain and crying.I had to place band aid and take him to the er as there was a lot of blood.We had not expected this.Bad, very bad.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9124353
• MDR Text Key: 160372200
• Report Number: MW5090054
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MALEM
• 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
• Patient Age: 6 YR