MAUDE Adverse Event Report: MALEM MEDICAL LTD MALEM ULTIMATE PRO BEDWETTING ALARM FOR BOYS AND GIRLS; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number ULTIMATE PRO ALARM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/23/2019

Event Type  Injury  

Event Description

We bought this item through (b)(6) to help potty train my son.The product worked decent for a short period (3 days) and then one night the flat metal plate that is part of the clip came undone and my son swallowed it.He was rushed to the emergency room and have to have xrays.I contacted the mfg, malem medical, and at first they were rude and told us not to report this incident to (b)(6) or the fda.I did not know this was a fda product till they told me, hence complaining.I would not recommend this product.It is intended for small children of potty training age and it is not made well.It is a dangerous product and a choking hazard.The company was rude and uncaring when contacted.Fda safety report id # (b)(4).

• Brand Name: MALEM ULTIMATE PRO BEDWETTING ALARM FOR BOYS AND GIRLS
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8848207
• MDR Text Key: 153136774
• Report Number: MW5088598
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE PRO ALARM
• Device Catalogue Number: LIGHT BLUE COLOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 4 YR