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

Model Number M043

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Our daughter has developed rash on skin from continued use of the bedwetting alarm.The rash is on the upper neck area where the alarm is connected on her.Was uncertain what was causing the same until we realized after about two weeks that each time the alarm would go off at night, it would also get hot.Though not dangerously hot, it would be sufficiently warm through the night.We visited the dr as well and he mentioned that this alarm brand is known to cause minor to severe burns from continued use.Discontinued use and left alarm with dr.Red patches on skin.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: 8776361
• MDR Text Key: 150711437
• Report Number: MW5087980
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M043
• Was Device Available for Evaluation?: No
• 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