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

Model Number XL WOMEN MAX

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

Patient Problems Abscess (1690); Antibiotics, Reaction To (1713)

Event Date 07/08/2016

Event Type  Injury  

Manufacturer Narrative

A document and records review was performed on the reported lot.Documentation assessed includes: manufacturing, quality audit, production, raw material and device history records.This assessment found no anomalies that may have attributed to the reported issue.A visual inspection of (b)(4) companion samples was conducted.The visual examination did not observe any product defects or abnormalities.The cause of the reported complaint could not be determined.Information from this incident will be included in our product complaint and mdr trend analysis.

Event Description

The consumer stated that while using disposable underwear, she developed redness and blisters on the vaginal area.She stated she first went to urgent care on (b)(6) 2016, which was of no help.The consumer stated that on (b)(6) 2016, she was seen by a different physician and admitted to the hospital with vulvar abscess and low white blood count.She stated that while she was in the hospital, she experienced an allergic reaction from zosyn which resulted in acute interstitial nephritis and shortness of breath.Her blood pressure skyrocketed, and she was admitted into icu and was put on a ventilator.She was discharged on (b)(6) 2016 and continued antibiotics and steroids.On (b)(6) 2016, the consumer reported that she has completed her antibiotics and the abscesses have healed.

• Brand Name: DEPEND UNDERGARMENTS
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION COLD SPRINGS; 1050 cold spring rd.; neenah WI 54956
• Manufacturer (Section G): KIMBERLY-CLARK CORPORATION COLD SPRINGS; 1050 cold spring rd.; neenah WI 54956
• Manufacturer Contact: angie masaro ; 2100 winchester road; neenah, WI 54956 ; 9207215934
• MDR Report Key: 5869937
• MDR Text Key: 51922777
• Report Number: 2184163-2016-00001
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/10/2016

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: Lay User/Patient
• Device Model Number: XL WOMEN MAX
• Device Lot Number: LF603917X0638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR