MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION - COLD SPRINGS DEPENDS UNDERGARMENT FOR WOMEN; TAMPON

Model Number XL MAX

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Laceration(s) (1946)

Event Date 05/06/2014

Event Type  Injury  

Event Description

The consumer stated that her incontinence garment cut her while wearing, causing her to bleed.She is currently in hospice care and has been diagnosed with lupus.She stated on (b)(6) 2014, she was cut by the fluff material inside the product causing her to bleed and be hospitalized.The cut later developed into an infection.She was prescribed antibiotics via iv and a steroid.On (b)(6) 2014, she had a fever and was fatigued.She plans to follow-up with her home nurse.

Manufacturer Narrative

Device history record is under review.Information from this incident will be included in our product complaint and mdr trend analysis.Consumer had not returned unused product for evaluation at the time of this report.

• Brand Name: DEPENDS UNDERGARMENT FOR WOMEN
• Type of Device: TAMPON
• 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: 3845555
• MDR Text Key: 19584669
• Report Number: 2184163-2014-00002
• 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: Other
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: XL MAX
• Device Lot Number: LF408817X0849
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2014
• 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 Age: 37 YR