MAUDE Adverse Event Report: MALEM MEDICALLTD. MALEM BEDWETTING ALARM 1 TONE ULTIMATE PRO ALARM ; ALARM, CONDITIONED RESPONSE ENURESIS

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 01/02/2020

Event Type  Injury  

Event Description

Our office has loaned out a new malem bedwetting alarm to pt suffering from primary nocturnal enuresis.Pt has used the alarm for 1 night and complained that alarm has caused significant injuries to child.The alarm has overheated at night when child was sleeping and injured her by causing skin burns where alarm was touching skin.I have requested parents to return alarm, but they have disposed it off.Pt's mother also complained that alarm was emitting fouls / burning smell when they discovered the incident.Pt is traumatized and worried.They have not returned to us for treatment so we can't determine how severe the incident is.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM 1 TONE ULTIMATE PRO ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICALLTD. ; lowdham, nottingham ; UK
• MDR Report Key: 9564314
• MDR Text Key: 174293159
• Report Number: MW5092089
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 01/04/2020

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 4 YR