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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALEM MEDICAL MALEM; BEDWETTING ALARM
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MALEM MEDICAL MALEM; BEDWETTING ALARM Back to Search Results
Model Number M04
Device Problems Burst Container or Vessel (1074); Overheating of Device (1437)
Patient Problems Pain (1994); Caustic/Chemical Burns (2549)
Event Date 01/15/2018
Event Type  Injury  
Event Description
We received a complaint from a mother last night that the enuresis alarm which was used by her (b)(6) child malfunctioned and overheated.This caused the batteries inside the alarm to overheat and explode.The batteries leaked onto the child's clothing and body and has seriously burnt the child.The parents brought the boy into the emergency treatment.Child was distraught and in pain from burns.The child was administered first aid and discharged after some time.The child has suffered minor burns and bruises from the faulty enuresis alarm.A f/u has been scheduled with the child and parent.We anticipate a recovery time of 2-4 weeks.
 
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Brand Name
MALEM
Type of Device
BEDWETTING ALARM
Manufacturer (Section D)
MALEM MEDICAL
lowdham, nottingham NG14 7EJ
UK  NG14 7EJ
MDR Report Key7202983
MDR Text Key97733087
Report NumberMW5074636
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 01/16/2018
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 No Information
Device Model NumberM04
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/17/2018
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) Hospitalization; Other;
Patient Age4 YR
Patient Weight18
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