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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ENURESIS ALARM; ENURESIS ALARM FOR CHILDREN
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MALEM MEDICAL LTD. MALEM ENURESIS ALARM; ENURESIS ALARM FOR CHILDREN Back to Search Results
Model Number M04S
Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Deformation Due to Compressive Stress (2889)
Patient Problem Burn, Thermal (2530)
Event Date 10/11/2018
Event Type  Injury  
Event Description
Our clinic has encountered at least 3 cases where the children were hurt by using the malem enuresis alarm.In each case, the child was sleeping at night when the incident happened.All children were between the age of 4 and 6 years.The alarms have developed defect causing explosion in all cases of the batteries and leaks on the child's body.This has in turn caused skin burn.The alarms were all new and we have the alarm if you need to analyze them.All three alarms have the back change in shape because of heat.All three alarms were new.The children were told to discontinue treatment and have to start using medication to counteract enuresis.Magenta.
 
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Brand Name
MALEM ENURESIS ALARM
Type of Device
ENURESIS ALARM FOR CHILDREN
Manufacturer (Section D)
MALEM MEDICAL LTD.
lowdham, nottingham NG14 7EJ
UK  NG14 7EJ
MDR Report Key7978716
MDR Text Key124312410
Report NumberMW5080624
Device Sequence Number1
Product Code KPN
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 10/15/2018
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberM04S
Was Device Available for Evaluation? Yes
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 Number1
Patient Outcome(s) Other;
Patient Age4 YR
Patient Weight17
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