MAUDE Adverse Event Report: EDGEWELL PERSONAL CARE O.B. ORIGINAL TAMPONS - APPLICATOR AND NON-APPLICATOR VERSIONS; TAMPON, MENSTRUAL, UNSCENTED

Lot Number 21029DA

Device Problem Material Fragmentation (1261)

Patient Problems Bacterial Infection (1735); Abnormal Vaginal Discharge (2123)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

An investigation was conducted that included a 24-month trend analysis, product risk documentation, review of the dhr and supporting documentation.The investigation showed no issues present that would have contributed to this malfunction of tampon performance.The investigation revealed no issues requiring corrective action with the product manufactured.

Event Description

Found a bunch of little fibers in my vaginal cavity [device material issue].On the 3 day i noticed a smell; after cycle, smell was still present; tampon fragments that caused odor [vaginal odour].Tampon fragments that caused [odor and a] bacterial infection [bacterial vaginosis].Case narrative: on (b)(6) 2021, a spontaneous report was received from a consumer regarding a (b)(6) old female who was using o.B.Original tampons - applicator and non-applicator versions (tampon, menstrual, unscented).Medical history and concomitant products were not reported.On an unspecified date, the consumer started use of o.B.Original tampons - applicator and non-applicator versions.On unspecified date(s) in (b)(6) 2021 (reported as "on day 3;" also reported as (b)(6) 2021 to (b)(6) 2021), after using the product, the consumer noticed a smell.She found no cause and made sure to change her tampons more frequently."after cycle," the smell was still present.Upon examination, she found "a bunch of little of tampon fibers in my vaginal cavity." there was no tampon left behind.Subsequently, the consumer spoke with a nurse who advised flushing vaginal cavity to get remaining fibers out and to see a doctor.On (b)(6) 2021, the consumer saw a doctor at a "walk-in-clinic." a "swab was taken," and the consumer's doctor confirmed there were no foreign objects or remnants, douching was effective, and there were signs of bacterial infection present.The consumer was treated with flagyl (metronidazole).She was always diligent on changing regularly (also reported as no tampon was left in over 7 hours) and using the correct size for flow, so she knew "it's not that." she was really "grossed out and disappointed." as of (b)(6) 2021, the status of product use was not reported, and the outcomes of the smell and bacterial infection were improved.No additional information was provided.

• Brand Name: O.B. ORIGINAL TAMPONS - APPLICATOR AND NON-APPLICATOR VERSIONS
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): EDGEWELL PERSONAL CARE; 6 research drive; shelton
• Manufacturer (Section G): EDGEWELL PERSONAL CARE
• Manufacturer Contact: 6 research drive; shelton
• MDR Report Key: 12315572
• MDR Text Key: 266306814
• Report Number: 2515444-2021-00018
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K974629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 21029DA
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR