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

Model Number MALEM ULTIMATE BEDWETTING ALARM

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Abrasion (1689); Laceration(s) (1946)

Event Date 10/17/2019

Event Type  Injury  

Event Description

Plastic lever on the sensor fell apart on first use and sensor dislodged from the underwear.The sensor has really sharp metal points exposed which cut my daughter.Her skin suffered a long shallow cut.There was no bleeding, but significant abrasion.We got lucky that it did not penetrate deep or she would be bleeding profusely at night.It's unsafe to use and unreliable.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: 9255193
• MDR Text Key: 164625446
• Report Number: MW5090756
• 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: 10/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MALEM ULTIMATE BEDWETTING ALARM
• Device Catalogue Number: M042
• 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: 5 YR