MAUDE Adverse Event Report: REASSURE REASSURE OVERNIGHT; DISPOSABLE OVERNIGHT UNDERWEAR

Device Problems Component Falling (1105); Gel Leak (1267); Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 10/25/2016

Event Type  Other  

Event Description

Caller is reporting that the gel substance can fall out of the underwear on the floor which can cause the user to fall and get injured.She stated that this product is used for older consumers and poses a safety risk.She stated that there have been 2 incidents, she fell the first time it occurred, but she was not injured seriously.No medical attention was received.The company was contacted and they informed her that they could discount her order.She declined their offer because the product is unsafe.Purchase date: (b)(6) 2016, this date is an estimate.

• Brand Name: REASSURE OVERNIGHT
• Type of Device: DISPOSABLE OVERNIGHT UNDERWEAR
• Manufacturer (Section D): REASSURE
• MDR Report Key: 6078465
• MDR Text Key: 59291067
• Report Number: MW5065802
• Device Sequence Number: 1
• Product Code: EYQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR