MAUDE Adverse Event Report: MALEM MEDICAL MALEM MEDICAL BEDWETTING ALARM; BEDWETTING (ENURESIS) ALARM

Model Number M04

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Burn(s) (1757); Erythema (1840); Tingling (2171); Electric Shock (2554)

Event Date 04/17/2017

Event Type  Injury  

Event Description

My step sons came over for the weekend and they suffer from primary nocturnal enuresis.I have recommended the (b)(6) website to patients as they send several catalogs to my office.I went online and purchased a malem ultimate bedwetting alarm for the older boy thinking it would be an effective and reliable solution.It came new and he used it over the weekends, but complained to me that would feel strange tingling when he wet.I explained that it was normal with the alarm.He refused to wear it after 5 weeks.He said that the alarm had given him many shocks and he was scared and already had redness on his genitals.I examined him and immediately told him to discontinue use of the product.I tested it by holding the alarm in my palm and pouring warm salt water on the special underwear that comes with it.Indeed, the alarm did give mild shocks.It was like a continuous stinging feeling like a tens machine.Currently he is undergoing treatment for his genital burns.

• Brand Name: MALEM MEDICAL BEDWETTING ALARM
• Type of Device: BEDWETTING (ENURESIS) ALARM
• Manufacturer (Section D): MALEM MEDICAL ; lowdham, nottingham, gb NG14 7EJ; UK NG14 7EJ
• MDR Report Key: 6529333
• MDR Text Key: 74024840
• Report Number: MW5069374
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• 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
• Patient Age: 8 YR
• Patient Weight: 33