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

Model Number M04S

Device Problem Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 11/29/2018

Event Type  Injury  

Event Description

We have received a complaint that the enuresis alarm our clinic had leased out to a patient has burnt the child during nighttime use.The alarm was leased in new condition for the treatment of nocturnal of enuresis 3 nights ago.Parents complained that the child was burnt in the neck.We are following up with parent and child, and will update.

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD. ; nottingham, lowdham ; UK
• MDR Report Key: 8129220
• MDR Text Key: 129432320
• Report Number: MW5081817
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M04S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization
• Patient Age: 5 YR
• Patient Weight: 26