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

Model Number M04S

Device Problem Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 09/11/2018

Event Type  Injury  

Event Description

Our clinic wishes to report two (2) instances of defect and malfunction of bedwetting alarms used by children.In both instances, the children were sleeping and using the bedwetting alarm which has failed to operate correctly and in both instances, the alarm burnt a child in sleep.Children are not related and separate cases.One reported to the clinic on (b)(6), the second on (b)(6).Both children are (b)(6) and were sleeping when parents reported children complaining of hot object touching skin.We have both alarms in our possession.These alarms were prescribed by the pediatrician (b)(6).The children were burnt in the neck area by the hot device and were treated in the clinic.They are recovering and f/u has been recommended.Our clinic is reporting and bringing the safety of this alarm to attention.Please ref #mw5080201.

• Brand Name: MALEM MEDICAL BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; lowdham, nottingham NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 7925416
• MDR Text Key: 122313016
• Report Number: MW5080234
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2018

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
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR
• Patient Weight: 23