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

Model Number M04S

Device Problems Leak/Splash (1354); Melted (1385); Overheating of Device (1437)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 09/15/2017

Event Type  Injury  

Event Description

A single mother brought in her (b)(6) son 2 nights ago for adverse event to an enuresis alarm.The child had suffered chemical burns from the enuresis alarm.On inspection, i determined that the alarm had malfunctioned and overheated and caused the 2 alkaline batteries to short out and leak on to the child's neck and chest area.The mother has confirmed that the alarm was used as recommended and she had used batteries that came with the alarm.Examination also showed that the batteries had not expired and were inserted correctly.The mother had said that this was the first night of use.The child was asleep with the alarm in use for 3 hours when the alarm overheated and caused batteries to lean.The acid from the battery leak has caused the child's skin to react adversely to the contamination.The back door of enuresis alarm has melted from the heat and has been seriously deformed.This alarm was used by a (b)(6) child for 3 hours and has caused temporary burns and skin reaction.

• Brand Name: MALEM MEDICAL
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL; UK
• MDR Report Key: 6875899
• MDR Text Key: 86622358
• Report Number: MW5072197
• 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: Physician
• Type of Report: Initial
• Report Date: 09/17/2017

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: Lay User/Patient
• Device Model Number: M04S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2017
• 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): Life Threatening
• Patient Age: 7 YR
• Patient Weight: 29