MAUDE Adverse Event Report: GREENBRIER INTERNATIONAL ASSURED; BLADDER CONTROL LINERS, LIGHT COUNT 20 COUNT; PERSONAL CARE

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Burning Sensation (2146)

Event Date 07/27/2016

Event Type  Injury  

Event Description

"assured: bladder control liners" purchased at the dollar store.This product has given me extreme urethritis.I have had terrible burning, seen 2 doctors and had 3 uti tests for bacteria, both negative.This product also has caused swelling around my urethra.I finally after several weeks made the connection between this panty liner and the pain and swelling.This product should be taken off of the shelf.Thanks, (b)(6).Incident location: other - (b)(6) united states.This is my home address.Document number:(b)(6).Report number:(b)(4).Retailer: (b)(6).Retailer state: (b)(6).Purchase date: 06/01/2016, this date is an estimate.Explanation: purchase 4 packages of 20.

• Brand Name: ASSURED; BLADDER CONTROL LINERS, LIGHT COUNT 20 COUNT
• Type of Device: PERSONAL CARE
• Manufacturer (Section D): GREENBRIER INTERNATIONAL
• MDR Report Key: 5868002
• MDR Text Key: 51998083
• Report Number: MW5064006
• Device Sequence Number: 0
• 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: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR