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

Device Problem Break (1069)

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

Event Date 04/14/2020

Event Type  Injury  

Event Description

While attaching the sensor on the underwear, the clip broke and the two thin and sharp metal discs were exposed.These cut my fingers and i started bleeding.The quality is fragile and albeit dangerous caused the sharp disc went deep into fingers.Device was intended for use by a (b)(6) year old son who would be bleeding if the incident had happened at night when he was asleep.Apparently lack of quality control and defective quality.Fda safety report id #: (b)(4).

• Brand Name: BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 9987221
• MDR Text Key: 188861942
• Report Number: MW5094221
• 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: 04/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• 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