MAUDE Adverse Event Report: EDGEWELL PERSONAL CARE CAREFREE ACTI-FRESH LINERS; PADS, MENSTRUAL

Model Number 078300069836.1

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

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

The consumer left a review on amazon that the liners were not individually wrapped to prevent bacteria and they were hospitalized for two weeks with a urine infection but did not report a malfunction that caused the issue.Edgewell was unable to obtain any additional information from the consumer.The consumer purchased the flat pack, non-individually wrapped liners vs.The to-go individually wrapped liners which are designed to be portable with an additional layer of protection from contaminants.The flat pack liners are intended to be used straight from the carton.An investigation was conducted that included a 24-month trend analysis and product risk documentation.No trend was identified during trend analysis.No manufacturers lot code was provided.With no means to ascertain the manufacturer/asset line and day of production, no further device history record investigation can be performed at this time.The investigation revealed no issues requiring corrective action with the product manufactured.

Event Description

Not individually wrapped to prevent bacteria end up hospitalized for two weeks; urine infection.[urinary tract infection bacterial].Case narrative: on 10-aug-2023, a spontaneous report was received from a consumer regarding a consumer (sex and age not reported) who was being treated with carefree acti-fresh liners (pad, menstrual).Medical history and concomitant products were not reported.On an unspecified date, the consumer started use with carefree acti-fresh liners.On an unspecified date, after using the product, the patient ended up hospitalized for 2 weeks with "urine infection." it was noted that the product was not individually wrapped to prevent bacteria.As of (b)(6) 2023, the status of product use was not reported, and the outcome of "urine infection" was not reported.No additional information was provided.

• Brand Name: CAREFREE ACTI-FRESH LINERS
• Type of Device: PADS, MENSTRUAL
• Manufacturer (Section D): EDGEWELL PERSONAL CARE; 804 walker rd; dover 19904
• Manufacturer (Section G): EDGEWELL PERSONAL CARE
• Manufacturer Contact: 804 walker rd; dover 19904
• MDR Report Key: 17702014
• MDR Text Key: 322879439
• Report Number: 2515444-2023-00019
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/07/2023

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: 078300069836.1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2023
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention