MAUDE Adverse Event Report: PLAYTEX MANUFACTURING INC. OB 40CT ORIGINAL REGULAR UNSCENTED; UNSCENTED MENSTRUAL TAMPONS

Lot Number	20091DD
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A female consumer, over the age of 18, reported that she used a tampon and when she tried to remove the plug, the string came out completely.Consumer stated that on the same day she had to go to the doctor's office to have the tampon removed.A culture was performed and the doctor recommended that she not use tampons for awhile to allow her body to cycle and heal.No medication or treatment was prescribed and no follow up appointment was needed.The consumer reported that she was healing.
Additional Manufacturer Narrative
Date of investigation: 12/09/2020.A 24-month trend ((b)(6) 2018-(b)(6) 2020) analysis was performed for product, date code and reason codes (string: pull out).While no trend has been noted by product, reason codes or date code, a request for investigation is being submitted since this case has been deemed reportable to the fda by epc medical affairs.It has been reported as a device malfunction due to the potential risk of serious illness to the consumer as medical care was required to remove the tampon.At this time this case's claim code status is non-verified medical claim.Per the process fmea for o.B tampons, a stringing issue that could result in a missing string has a severity rating of 6, meaning serious.A serious severity is described as having performance impact, up to and including product failure with potential for harm to the patient or user due to failure of the product to meet performance expectations.Major physical injury possible of a temporary nature with reversible symptoms.The occurrence of the defect is listed as remote and the overall risk level is low, which does not require mitigation.Device history record review was conducted on lot 20091dd, ob 40ct original regular unsc.During the production of this product there were no nonconformances associated with the forming lots or the pack lot of the tampon.All samples passed visual inspections, absorbency testing, ejection force testing and string performance testing.Review of the dhr and supporting documentation showed no issues present that would have contributed to this malfunction of tampon performance.
Event or Problem Description
A female consumer, over the age of 18, reported that she used a tampon and when she tried to remove the plug, the string came out completely.Consumer stated that on the same day she had to go to the doctor's office to have the tampon removed.A culture was performed and the doctor recommended that she not use tampons for awhile to allow her body to cycle and heal.No medication or treatment was prescribed and no follow up appointment was needed.The consumer reported that she was healing.Additional information 12/09/2020: investigation results added in additional manufacturer narrative section.

• Brand Name: OB 40CT ORIGINAL REGULAR UNSCENTED
• Common Device Name: UNSCENTED MENSTRUAL TAMPONS
• Manufacturer (Section D): PLAYTEX MANUFACTURING INC.; 804 walker rd,; dover DE 19904
• MDR Report Key: 10928599
• Report Number: 2515444-2020-00010
• Device Sequence Number: 3019385
• Product Code: HEB
• UDI-Device Identifier: 00078300070085
• UDI-Public: 078300070085
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K023789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: 20091DD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/18/2020
• 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