MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLPEARLMIXEDDO34CT; TAMPON, MENSTRUAL, SCENTED

Lot Number 015524301496

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

A product investigation is in progress.

Event Description

A 3 inch mesh piece of plastic was left inside vagina [foreign body in reproductive tract].Took out the tampon, and it left a 3 inch mesh piece of plastic inside vagina [complication of device removal].Tampon left a 3 inch mesh piece of plastic inside [device breakage].Case description: consumer called stating she took out the tampon, and it left a 3 inch mesh plastic piece in her vagina.No serious injury was reported.

Manufacturer Narrative

25-sep-2020 product investigation results: no failure could be identified as a result of the investigation.

Event Description

3 inch mesh piece of plastic inside vagina [foreign body in reproductive tract].Took out the tampon and it left a 3 inch mesh piece of plastic inside vagina [complication of device removal].Tampon left a 3 inch mesh piece of plastic inside [device breakage].Case description: consumer called stating she took out the tampon, and it left a 3 inch mesh plastic piece in her vagina.No injury was reported.

• Brand Name: TAMPAXTAMPONSPEARLPEARLMIXEDDO34CT
• Type of Device: TAMPON, MENSTRUAL, SCENTED
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn ME 04210
• MDR Report Key: 10459696
• MDR Text Key: 205523755
• Report Number: 1219109-2020-00243
• Device Sequence Number: 1
• Product Code: HIL
• Combination Product (y/n): N
• PMA/PMN Number: K081555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 015524301496
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR