MAUDE Adverse Event Report: KIMBERLY-CLARK PERSONAL HYGIENIC PRODUCTS CO. ,LTD DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ

Model Number INCONTINENCE SHIELDS FOR MEN, LIGHT ABSORBENCY

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

Patient Problems Irritation (1941); Pain (1994); Urinary Tract Infection (2120); Burning Sensation (2146)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

A manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.

Event Description

Consumer reported he experienced a burning, painful irritation in the groin area and was using cream and toilet paper as a barrier while wearing the pads.He had blood in his urine after wearing a pad for three days.He was diagnosed with a urinary tract infection and hospitalized for one day.While in the hospital he was administered iv antibiotics and given 850mg pills that he took for two weeks.He no longer had blood in his urine and his symptoms had improved.He stopped using the pads.

• Brand Name: DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY-CLARK PERSONAL HYGIENIC PRODUCTS CO. ,LTD; no. 2 jian an street; economic technology; development zone, beijing 10017 6; CH 100176
• Manufacturer (Section G): KIMBERLY-CLARK PERSONAL HYGIENIC PRODUCTS CO. ,LTD; no. 2 jian an street; economic technology; development zone, beijing 10017 6; CH 100176
• Manufacturer Contact: chris maertz ; 2100 winchester rd; neenah, WI 54956 ; 9207214907
• MDR Report Key: 8713400
• MDR Text Key: 148463518
• Report Number: 9615625-2019-00001
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INCONTINENCE SHIELDS FOR MEN, LIGHT ABSORBENCY
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 87 YR