MAUDE Adverse Event Report: BEDWETTING STORE AND MALEM MEDICAL MALEM BEDWETTING ALARM; ENURESIS ALARM

Lot Number NONE

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 09/11/2017

Event Type  Injury  

Event Description

The malem bedwetting alarm that i purchased from the bedwetting store overheated and burnt my child on his chest and neck.The incident happened the very first day we used this bedwetting alarm.My (b)(6) son connected it on his pajama top and went to sleep.Few hours later he screamed out loud and we noticed that the alarm had overheated and caused him serious burns.There is some serious fault in the mechanics of this product.We had to rush him to the doctors for help.This kind of quality is unacceptable.Manufacturers details are as follows: (b)(4).The fda needs to look into this product asap.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): BEDWETTING STORE AND MALEM MEDICAL
• MDR Report Key: 6885734
• MDR Text Key: 87190611
• Report Number: MW5072267
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR