MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION - COLD SPRINGS DEPEND UNDERGARMENTS FOR WOMEN; INCONTINENCE GARMENT

Model Number LONG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 01/01/2013

Event Type  Injury  

Event Description

This is a non-us event.The event occurred in (b)(6).The consumer stated that she experienced a bladder infection after incontinence garment usage.She indicated that she purchased the undergarment for women several months ago.After usage, she experienced painful urination with slight burning.She saw a kidney specialist and was prescribed medication.She stated that she is allergic to perfume and feels her symptoms are related to fragrance in the product.She was advised that the product does not contain fragrances and has since discontinued use.She indicated that she feels better now.She is planning to follow-up with her physician on (b)(6) 2014.

Manufacturer Narrative

The complaint sample was not available; therefore, a product evaluation was not performed.Document and record review was performed for reported manufacture lot lf307614x1154.Documentation assessed includes: manufacturing, production, quality audit, raw material, device history record, sanitization, and finished product bio-burden.This evaluation found no anomalies that may have attributed to the reported issue.Also, a trend analysis of the (b)(4) database found no other complaints against the reported/continuous manufactured lots under the same complaint category and machine.Root cause could not be identified.

• Brand Name: DEPEND UNDERGARMENTS FOR WOMEN
• Type of Device: INCONTINENCE GARMENT
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION - COLD SPRINGS; 1050 cold spring road; neenah WI 54956
• Manufacturer Contact: charnelle thomas ; 1400 holcomb bridge rd.; roswell, GA 30076 ; 6783526031
• MDR Report Key: 3562210
• MDR Text Key: 4212307
• Report Number: 2184163-2014-00001
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2013

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?: No
• Device Operator: Other
• Device Model Number: LONG
• Device Lot Number: LF307614X1154
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2013
• Initial Date FDA Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR