MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLPEARLSUPERPLUSDO18CT; TAMPON, MENSTRUAL, SCENTED

Lot Number NOT AVAILABLE

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

There is insufficient information to perform a product investigation.

Event Description

Big piece of tampon in vagina [foreign body in reproductive tract].Tampon falling apart inside [device breakage].Case description: consumer reported via phone that tampon is falling apart inside her.No serious injury reported.

• Brand Name: TAMPAXTAMPONSPEARLPEARLSUPERPLUSDO18CT
• Type of Device: TAMPON, MENSTRUAL, SCENTED
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn ME 04210
• Manufacturer (Section G): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn ME 04210
• Manufacturer Contact: mgr. regulatory feminine care ; winton hill business center; b6280 center hill avenue; cincinnati, OH 45224
• MDR Report Key: 12247560
• MDR Text Key: 264152371
• Report Number: 1219109-2021-00267
• Device Sequence Number: 1
• Product Code: HIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081555
• 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: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2021
• 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