MAUDE Adverse Event Report: MALEM MEDICAL, LTD MALEM BED-WETTING ALARM; ALARM CONDITIONED RESPONSE ENURESIS

Model Number M-04-SC

Device Problems Overheating of Device (1437); Vibration (1674)

Patient Problem Bruise/Contusion (1754)

Event Date 01/30/2019

Event Type  Injury  

Event Description

Parents unsuccessfully tried treatments to stop bedwetting in (b)(6) year old girl.At the recommendation of pediatrician, parents started using a bedwetting alarm.A new alarm was placed on child and sensor on the outside of underwear.Parents put child to bed.At night, when child wet the bed, the alarm beeped but did not vibrate.The vibration erratic and seemed stuck.Parents heard the beeping after 20-30 minutes (approximately) and went to wake up daughter.Mother notices strange smell from the alarm and pulled it to remove it.She noticed that the alarm was very hot and there was black matter on the outside of the alarm.She had a hard time removing it because it was very hot.The alarm detected bedwetting, however it failed to be safe and overheated at night when girl was asleep.The alarm kept beeping on removal and buttons did not function.It was not possible to remove the batteries because of heat.Child has bruises from contact with alarm.She has had three follow-up visits to our clinic to treat her condition.Currently child and parent are traumatized by the accident and have discontinued using the product.

• Brand Name: MALEM BED-WETTING ALARM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD
• MDR Report Key: 8320378
• MDR Text Key: 136112241
• Report Number: MW5083836
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-04-SC
• Was Device Available for Evaluation?: No
• 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 Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 11 YR
• Patient Weight: 39