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

Model Number M-04

Device Problems Display or Visual Feedback Problem (1184); Vibration (1674); Defective Device (2588); Scratched Material (3020); Noise, Audible (3273)

Patient Problem Rash (2033)

Event Date 01/28/2019

Event Type  Injury  

Event Description

Dr.(b)(6) prescribed an enuresis alarm for his patient.The patient has nocturnal enuresis and is autistic.The parents purchased a malem alarm from (b)(6) website.Alarm is defective.Patient was asleep and wet the bed.In response, the alarm went off but the patient did not get up.Parents reached to child on hearing the alarm and when they removed the alarm, they noticed the alarm had got hot and was ringing and vibrating.The hot alarm made the batteries leak and spill on child¿s body.Patient has been treated for skin rash and is receiving treatment.Alarm has been discontinued.Blue colour.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; lowdham, nottingham ; UK
• MDR Report Key: 8306473
• MDR Text Key: 135704951
• Report Number: MW5083701
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/31/2019

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: Health Professional
• Device Model Number: M-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2019
• 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