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

Model Number ULTIMATE ALARM FOR BEDWETTING

Device Problem Defective Component (2292)

Patient Problem Burn, Thermal (2530)

Event Date 05/24/2019

Event Type  Injury  

Event Description

Our clinic has received complaints of defects in bedwetting alarm used by our patient.The user is a (b)(6) girl who on the advice of our pediatrician started using an enuresis alarm.The intent was to stop her by awakening her on detecting urine.The alarm has however, developed a defect on day 3 of use.The patients said that the first night it was used, it did not detect urine.On the second day, the volume level fell low and the alarm until was acting erratic and going off for no reason, so they did not use it.On the third day, they replaced batteries and reused.The young girl was asleep in bed when the alarm malfunctioned for no apparent reason and injured the child.The result was that she was burnt on her skin at the neck area.Although the burns were minor, they have resulted in stress and fear on the child.Family has discontinued using the alarm.We have treated the patient and requested follow up.The alarm has been returned to the place of purchase.Fda security report id # (b)(4).

• Brand Name: ENURESIS ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; GB
• MDR Report Key: 8692318
• MDR Text Key: 147944870
• Report Number: MW5087282
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2019

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: Other
• Device Model Number: ULTIMATE ALARM FOR BEDWETTING
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR