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

Model Number ULTIMATE PRO BEDWETTING ALARM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Rash (2033); Skin Inflammation (2443)

Event Date 10/16/2019

Event Type  Injury  

Event Description

My daughter has been consistently using the device for the last 2 weeks.After a week of use, she developed skin rash and at the place where the alarm was touching her.Discontinued use and the skin rash got better and faded away.We restarted treatment and the rash reappeared.It is clearly being caused as a result of the alarm touching her skin.Something with the alarm is dangerous and not normal.It is causing severe skin rash and red patches which are also painful.It is exactly where the alarm is touching her.Discontinued use and she is getting better.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: 9249668
• MDR Text Key: 164397255
• Report Number: MW5090726
• 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: 10/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO 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: 7 YR