MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLPEARLSUPERDO36CT; TAMPON, MENSTRUAL, SCENTED

Lot Number 0335243067W 08:37

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

Piece of tampon broken off.Tried getting it out myself- vagina [foreign body in reproductive tract].Top piece of tampon broken off [device breakage].Pulled out tampon, top piece had broke off, retained [complication of device removal].Consumer reported via e-mail that piece of tampon broke off during removal.No serious injury was reported.

Manufacturer Narrative

A product investigation is in progress.

Event Description

Piece of tampon broken off.Tried getting it out myself- vagina [foreign body in reproductive tract].Top piece of tampon broken off [device breakage].Pulled out tampon, top piece had broke off, retained [complication of device removal].Case description: consumer reported via e-mail that piece of tampon broke off during removal.No serious injury was reported.

Manufacturer Narrative

No failure could be identified as a result of the investigation.

Event Description

Piece of tampon broken off.Tried getting it out myself- vagina [foreign body in reproductive tract] top piece of tampon broken off [device breakage] pulled out tampon, top piece had broke off, retained [complication of device removal] case description: consumer reported via e-mail that piece of tampon broke off during removal.No serious injury was reported.

• Brand Name: TAMPAXTAMPONSPEARLPEARLSUPERDO36CT
• Type of Device: TAMPON, MENSTRUAL, SCENTED
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel road; auburn ME 04210
• Manufacturer (Section G): TAMBRANDS MANUFACTURING, INC; 2879 hotel road; auburn ME 04210
• Manufacturer Contact: mgr. regulatory feminine care ; winton hill business center; b6280 center hill avenue; cincinnati, OH 45224
• MDR Report Key: 11869687
• MDR Text Key: 252160633
• Report Number: 1219109-2021-00180
• 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,Followup,Followup
• Report Date: 04/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 0335243067W 08:37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2022
• 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
• Patient Sex: Female