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 Type  Injury  

Event Description

Tampon coming out in pieces [device breakage].Case narrative: on 06-feb-2023, a spontaneous report was received from a consumer regarding a consumer who was using playtex sport plastic, unscented (tampon, menstrual, unscented).Medical history and concomitant products were not reported.On an unspecified date, the consumer started use of playtex sport plastic, unscented.On an unreported date, after inserting the product, the consumer's tampon was coming out in pieces.The consumer ended up in urgent care to have it removed and it took several minutes for them to retrieve all the pieces.As of 06-feb-2023, the status of product use was not reported.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: 16491501
• MDR Text Key: 310771778
• Report Number: 2515444-2023-00007
• 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: 03/06/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2023
• 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