MAUDE Adverse Event Report: EDGEWELL PERSONAL CARE PLAYTEX SPORT PLASTIC, UNSCENTED; TAMPON, MENSTRUAL, UNSCENTED

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/08/2023

Event Type  Injury  

Event Description

Half of it broke off inside of me; tampon broke [device breakage].Tampon broke and was left inside of her; removal of tampon, doctor removed [foreign body in reproductive tract].Case narrative: on (b)(6) 2023, a spontaneous report was received from a consumer regarding a 31-year-old white, caucasian female who was using playtex sport plastic, unscented (tampon, menstrual, unscented).On 19-sep-2023, additional information was received from a consumer, and based on the information the case was upgraded to 30-day report.Medical history and concomitant products were not reported.On an unspecified date, the patient started using playtex sport plastic, unscented.On (b)(6) 2023, 5 days after starting use of the product, the patient placed a tampon in and when she removed it, half of the tampon broke off inside of her (also reported as ripped off).Subsequently, she made an appointment with a doctor to make sure all of the material was out of her.On (b)(6) 2023, the doctor removed the tampon.As of (b)(6) 2023, the status of product use was discontinued temporarily, but she was planned to use it again.No additional information was provided.

Manufacturer Narrative

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.

• Brand Name: PLAYTEX SPORT PLASTIC, UNSCENTED
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• 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: 17964740
• MDR Text Key: 326027845
• Report Number: 2515444-2023-00025
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2023
• 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): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Race: White