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

Model Number M04SB

Device Problem Product Quality Problem (1506)

Patient Problems Discomfort (2330); Electric Shock (2554)

Event Date 05/08/2020

Event Type  Injury  

Event Description

This malem bedwetting alarm is terrible.It does not work as described.It doesn't detect urine even when it's supposed to and rings with scary tones when it's dry.It's hard to program, we followed the directions and it doesn't work.The sensor is extremely uncomfortable, it kept hurting my child in his groin all the time.When my son had bedwetting accident, the sensor gave him a big bad shock in his groin at night.He was scared, worried and cried.The alarm kept giving him a shock till i heard him cry and went to his room to remove it.Overall this is a substandard overpriced toy.We are very disappointed with this product.I very much regret the money we wasted on this and do not recommend it at all.This product has demotivated my son and now his bedwetting has gone worse.Fda safety report id # (b)(4).

• Brand Name: BEDWETTING ENURESIS ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 10051379
• MDR Text Key: 191010103
• Report Number: MW5094466
• 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: 05/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04SB
• Device Catalogue Number: M04SB
• 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): Required Intervention
• Patient Age: 7 YR