MAUDE Adverse Event Report: MALEM MEDICAL LTD BED-WETTING ALARM; ALARM CONDITIONED RESPONSE ENURSIS

Model Number M04S

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 09/11/2018

Event Type  Injury  

Event Description

A malfunction in my daughter's bed-wetting device has caused burn marks on the point of contact.The bed-wetting alarm is clipped on her shirt and the alarm comes in contact with her neck.At night, the alarm was very hot and burnt her neck.We took her to the er for treatment.She has recovered but is traumatized from the incident.She is worried that she may never be able to stop bed-wetting and refuses to use another device.Our malem alarm is quite dangerous and it was shipped back to (b)(4) where it was purchased.

• Brand Name: BED-WETTING ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURSIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7889018
• MDR Text Key: 120837119
• Report Number: MW5079869
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2018
• 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
• Patient Weight: 17