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

Device Problem Break (1069)

Patient Problems Laceration(s) (1946); Blood Loss (2597)

Event Type  Injury  

Event Description

The malem bedwetting alarm clip sensor broke into two pieces while i was placing it on my son's underwear and cut my hand.The lever clip broke and the sharp iron just lodged into my palm and cut it.I had to go to the dr's office.The cut was very deep and bleeding was for several hours.Not safe for a child who is sleeping.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE PRO BEDWETTING ALARM BY MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9145213
• MDR Text Key: 161003293
• Report Number: MW5090132
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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