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

Model Number 1 TONE DEVICE

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 01/12/2020

Event Type  Injury  

Event Description

Last night, while removing the bedwetting alarm sensor from my daughter's underwear, the lever on the sensor came loss and fell off.There was a sharp metal point which was protruding from the tip.It lodged in her underwear and cut her on the inner thigh.It was sharp like a knife and she was bleeding.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9596190
• MDR Text Key: 175650886
• Report Number: MW5092292
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1 TONE DEVICE
• Device Catalogue Number: ULTIMATE PRO ALARM
• 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: 7 YR