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

Model Number OPEN END

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Abrasion (1689); Bacterial Infection (1735)

Event Type  Injury  

Event Description

The patient stated that one of the layers of a cardboard applicator tampon tube was split and she did not notice the until after she had used the tampon.The defect caused her vagina to be scratched and she was in pain for four or five days.She went to her physician who gave her pain pills and a cream to numb the pain (the type of cream and pills was not identified by the patient).A few days later the patient still had pain and went to a local hospital emergency room.The attending physician prescribed antibiotics, the pain has receded and she is feeling better.No dates of events or physician actions were provided by the patient.

Manufacturer Narrative

A review of the dhr showed that all processes and inspections were completed as required and that no product defects related to the reported issue were encountered.Representative retain samples were inspected for defects or physical damage to the applicator tube and none were seen.A check of the complaint database showed no other reports of similar defects or injuries associated with the production lot, along with no adverse trends in applicator defects.Although the patient indicated an intent to return unused tampons from the original carton in a postage paid envelope sent to the patient, none have been returned as of the date of this report.If further information becomes available, a follow-up report will be provided.

• Brand Name: FEMTEX PRIVATE LABEL TAMPONS
• Type of Device: VAGINAL TAMPON
• Manufacturer (Section D): FIRST QUALITY HYGIENIC, INC.; mcelhattan PA
• Manufacturer Contact: mark loewen ; 121 north rd.; clinton county industrial park; mcelhattan, PA 17748 ; 5707694841
• MDR Report Key: 3581332
• MDR Text Key: 4167162
• Report Number: 2529605-2014-00001
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: OPEN END
• Device Lot Number: 13CRC26
• Other Device ID Number: 036800319202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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 Outcome(s): Required Intervention