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

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

An investigation was conducted that included a 24-month trend analysis and product risk documentation.No device history record investigation can be done at this time due to lack of manufacturer¿s lot code supplied with the complaint.Trend analysis did not reveal any trends for the product.We cannot determine this complaint¿s association with any lots of known identity due to lack of manufacturer¿s lot code.The investigation revealed no issues requiring corrective action with the product manufactured.

Event Description

String detached from the cotton; the string broke off leaving the tampon inserted and the string in my hand.[device breakage].Leaving the tampon unable to remove; was reviewed and tampon successfully removed; went to remove tampon; tried to retrieve the tampon with my fingers but was unable [foreign body in reproductive tract].Case narrative: on (b)(6) 2024, a spontaneous report was received from a consumer regarding a 61-year-old female who was using o.B.Original tampons (tampon, menstrual, unscented).On 09-feb-2024, additional information was received from a consumer.On 05-mar-2024, additional information was received from a consumer.Medical history and concomitant products were not reported.On an unspecified date (reported as for years, relative to (b)(6) 2024), the patient started use with o.B.Original tampons.On (b)(6) 2024, after starting the product, the patient took a trip to urgent care to retrieve a tampon where the string detached from the cotton leaving the tampon unable to remove.The tampon was successfully removed by a provider.As of 09-feb-2024, continued use of the product was not reported.No additional information was provided.On (b)(6) 2024, it was learned that the patient went to remove tampon and the string broke off leaving the tampon inserted and the string in her hand.She tried to retrieve the tampon with her fingers but was unable and thus needed to seek medical help for assistance.Urgent care was her only option.She had used o.B.For several years with no issues.As of 05-mar-2024, the status of product use was not reported.No additional information was provided.

• Brand Name: O.B. ORIGINAL TAMPONS - APPLICATOR AND NON-APPLICATOR VERSIONS ULTRA
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): EDGEWELL PERSONAL CARE; 804 walker rd; dover 19904
• Manufacturer (Section G): EDGEWELL PERSONAL CARE
• Manufacturer Contact: 804 walker rd; dover 19904
• MDR Report Key: 19055450
• MDR Text Key: 339549648
• Report Number: 2515444-2024-00099
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/05/2024

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female