MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ALARMS; ENURESIS ALARMS

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 01/02/2017

Event Type  Injury  

Event Description

This report pertains several pts who have had adverse effects using the malem brand of enuresis alarm.I have been prescribing these alarms to my pts for the last 4-6 months, when i was first introduced to the product at a medical conference.The company demonstrated the products and sent me catalogs which i have given pts.Three of my pts have complained that the enuresis alarm has malfunctioned at night.In all these cases, the back of the alarm unit which houses batteries overheated and in one case, the batteries melted and burnt a hole in the users' clothing.The children who used these products suffered from burns near the neck and chest area.They all were under the age of 7.Each child was asleep when the incidents took place and the alarms were placed by the parent so there was no use error.I can only infer that these enuresis alarms have a design flaw which causes overheating and burns on the children's necks and torso region.All three children were brought to my attention and i treated them for minor burns.Done over time.It is possible that more cases may arise.These will be reported.(b)(6)- online website.

Event Description

This report pertains several pts who have had adverse effects using the malem brand of enuresis alarm.I have been prescribing these alarms to my pts for the last 4-6 months, when i was first introduced to the product at a medical conference.The company demonstrated the products and sent me catalogs which i have given pts.Three of my pts have complained that the enuresis alarm has malfunctioned at night.In all these cases, the back of the alarm unit which houses batteries overheated and in one case, the batteries melted and burnt a hole in the users' clothing.The children who used these products suffered from burns near the neck and chest area.They all were under the age of 7.Each child was asleep when the incidents took place and the alarms were placed by the parent so there was no use error.I can only infer that these enuresis alarms have a design flaw which causes overheating and burns on the children's necks and torso region.All three children were brought to my attention and i treated them for minor burns.Done over time.It is possible that more cases may arise.These will be reported.(b)(6) - online website.

Event Description

This report pertains several pts who have had adverse effects using the malem brand of enuresis alarm.I have been prescribing these alarms to my pts for the last 4-6 months, when i was first introduced to the product at a medical conference.The company demonstrated the products and sent me catalogs which i have given pts.Three of my pts have complained that the enuresis alarm has malfunctioned at night.In all these cases, the back of the alarm unit which houses batteries overheated and in one case, the batteries melted and burnt a hole in the users' clothing.The children who used these products suffered from burns near the neck and chest area.They all were under the age of 7.Each child was asleep when the incidents took place and the alarms were placed by the parent so there was no use error.I can only infer that these enuresis alarms have a design flaw which causes overheating and burns on the children's necks and torso region.All three children were brought to my attention and i treated them for minor burns.Done over time.It is possible that more cases may arise.These will be reported.(b)(6) - online website.

• Brand Name: MALEM ALARMS
• Type of Device: ENURESIS ALARMS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 6328522
• MDR Text Key: 67477529
• Report Number: MW5067851
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2017

1 Device was Involved in the Event

3 Patient was Involved in the Event

• Date FDA Received: 02/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SEVERAL
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 6 YR