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

Device Problem Defective Device (2588)

Patient Problems Erythema (1840); Pain (1994); Rash (2033); Swelling (2091)

Event Date 12/26/2016

Event Type  Injury  

Event Description

The bedwetting alarm has been used for several days (8 nights).Son has developed severe skin rash to the alarm.The place there the alarm is clipped is red with small blisters and the cable has also caused red marks.There is something in the alarm that is either unsafe or bad for skin.After 4 nights, i used alcohol wipes to disinfect the alarm and cord and retried, but it's not helping.Son is in pain and has to use lotion.This is not the side effect.Something wrong with the product.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: 9540129
• MDR Text Key: 173648870
• Report Number: MW5091994
• 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: 12/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR