MAUDE Adverse Event Report: FIRST QUALITY HYGIENIC , INC FEMTEX PRIVATE LABEL TAMPON; VAGINAL TAMPON

Lot Number	6 247 0815
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Samples were not received back from patients.Retain samples were evaluated and physically inspected.No defects found.Eact product simgle use and disposed of.
Event or Problem Description
Patient stated she purchased a box of tampons.She stated this was not her normal brand but she wanted to save money due to christmas.Patient stated she used the product and one of the tampons broke off and got stuck inside her for a month causing an infection.Patient stated that she did not notice anything odd when she removed the tampon.She stated she does not look at her tampons, she pulls it out and drops them in the toilet to be flushed.Patient stated she became pregnant after the tampon was lodged in her.She stated that the sperm got past the lodged tampons and impregnated her.Patient stated she was about (b)(6) pregnant.Patient stated that she thought she had a uti and it would pass.She stated she then started having irregular bleeding and an odd smell.Patient stated she went to the hospital.Snhe stated that a doctor performed an exam and removed the tampon piece.Patient stated the doctor diagnosed her with an infection which the patient called "endometriosis".Patient stated she is no longer pregnant.

• Brand Name: FEMTEX PRIVATE LABEL TAMPON
• Common Device Name: VAGINAL TAMPON
• Manufacturer (Section D): FIRST QUALITY HYGIENIC , INC; 121 north rd; clinton county industrial park; mcelhattan PA 17748
• MDR Report Key: 6283495
• Report Number: 2529605-2017-00001
• Device Sequence Number: 674488
• Product Code: HEB
• UDI-Device Identifier: 00748364500797
• UDI-Public: 748364500797
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K023479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/25/2017

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
• Operator of Device: Lay User/Patient
• Device Lot Number: 6 247 0815
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/28/2016
• Device Age: 1 YR
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2016
• Initial Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Weight: 73