MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLREGNORDO18CT; 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

Would like to know how to remove (tampon) - rectum [foreign body in gastrointestinal tract].Tampon in butt [incorrect route of product administration].Put a tampon in butt [intentional device misuse].Put tampon in butt [exposure via mucosa].Would like to know how to remove (tampon) [device malfunction].Case description: consumer contacted via phone and stated that his/her sister put a tampon in her butt; the consumer stated that he/she would like to know how to remove the tampon.No serious injury was reported.

• Brand Name: TAMPAXTAMPONSPEARLREGNORDO18CT
• Type of Device: TAMPON, MENSTRUAL, SCENTED
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel road; auburn, me
• Manufacturer (Section G): TAMBRANDS MANUFACTURING, INC; 2879 hotel road; auburn, me
• Manufacturer Contact: regulatory feminine care ; winton hill business center; b6280 center hill avenue; cincinnati, oh
• MDR Report Key: 10238800
• MDR Text Key: 197774256
• Report Number: 1219109-2020-00155
• 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: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• 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: 05/19/2020
• 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