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

Model Number MODEL M

Device Problems Leak/Splash (1354); Melted (1385); Deformation Due to Compressive Stress (2889); Temperature Problem (3022)

Patient Problem Pain (1994)

Event Date 05/04/2019

Event Type  Injury  

Event Description

Over the weekend, our son tried using a bedwetting product which has a severe defect.The product, was new and did not show any signs of abuse or damage when it was received.I set up on him and we watched instructions on using it.He went to bed with the product on him and came out 30 mins later.He was complaining that the alarm was hurting him while he was asleep.I checked into the alarm and it was burning hot.I was unable to hold it.The alarm was hot like i was on fire.Fortunately my son is (b)(6) and was able to remove it promptly, but if not, he would be seriously injured from this incident.I was not able to remove batteries on time and the alarm just leaked out the batteries and the underside partially melted and deformed from heat.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8604762
• MDR Text Key: 145010210
• Report Number: MW5086573
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MODEL M
• Device Catalogue Number: 044
• Device Lot Number: GOLD COLOR
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR