MAUDE Adverse Event Report: EDGEWELL PERSONAL CARE PLAYTEX SPORT PLASTIC, UNSCENTED; TAMPON, MENSTRUAL, UNSCENTED

Lot Number 22271CA

Device Problem Material Separation (1562)

Patient Problems Menstrual Irregularities (1959); Pain (1994); Discomfort (2330); Foreign Body In Patient (2687); Genital Bleeding (4507)

Event Date 02/04/2023

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.No trends were identified for the lot or product.Review of the dhr and supporting documentation showed no evidence of issues present that would have an association with this malfunction of tampon performance.The investigation revealed no issues that would require corrective action for the product manufactured.

Event Description

Having this product removed in pieces, doctor removed it, it came out in pieces, string frayed apart [device breakage].String was completely sucked up inside and covered in blood [foreign body in reproductive tract].Case narrative: on 04-feb-2023, a spontaneous report was received from a consumer regarding a 16-year-old female who was using playtex sport plastic, unscented (tampon, menstrual, unscented).On 07-feb-2023, additional information was received from a consumer.Medical history and concomitant products were not reported.On an unspecified date, the patient started use with playtex sport plastic, unscented.On (b)(6) 2023, after inserting the product and having the product inserted for at least 12 hours, the consumer tried to remove the product.The string frayed apart and was completely sucked up inside and covered in blood, and the product was stuck.The consumer's mother took her to their local urgent care center and the physician removed the tampon which came out in pieces and flushed the consumer with saline solution to ensure that no particles were left inside the consumer.The consumer took over-the-counter ibuprofen for cramps.As of 07-feb-2023, the status of product use was not reported, and the consumer was recovered and well.No additional information was provided.

Event Description

Having this product removed in pieces, doctor removed it, it came out in pieces, string frayed apart [device breakage].String was completely sucked up inside and covered in blood [foreign body in reproductive tract].Much discomfort (cried the entire time) [discomfort].Case narrative: on (b)(6) 2023, a spontaneous report was received from a consumer regarding a 16-year-old female who was using playtex sport plastic, unscented (tampon, menstrual, unscented).On (b)(6) 2023, additional information was received from a consumer.On (b)(6) 2023, additional information was received from anonymous reporter.Medical history and concomitant products were not reported.On an unspecified date, the patient started use with playtex sport plastic, unscented.On (b)(6) 2023, after inserting the product and having the product inserted for at least 12 hours, the consumer tried to remove the product.The string frayed apart and was completely sucked up inside and covered in blood, and the product was stuck.The consumer's mother took her to their local urgent care center and the physician removed the tampon which came out in pieces and flushed the consumer with saline solution to ensure that no particles were left inside the consumer.The consumer took over-the-counter ibuprofen for cramps.As of (b)(6) 2023, the status of product use was not reported, and the consumer was recovered and well.No additional information was provided.On (b)(6) 2023, it was learned that on an unspecified date in (b)(6) 2023 (reported as on (b)(6) 2023; previously reported as (b)(6) 2023), the patient tried to remove the product before bed, but the string could not be located.The consumer did not know what to do and went to bed.The next morning, the consumer told her mother who promptly took her to the urgent care.It took several minutes to remove the product with forceps followed by irrigation.Pieces broke off and were removed individually.Bits were also present in the irrigated fluid.The patient cried the entire time, and she experienced much discomfort.It was previously reported consumer had subsequently recovered and was well.No additional information was provided.

Manufacturer Narrative

An investigation was conducted that included a 24-month trend analysis, product risk documentation, review of the dhr and supporting documentation.No trends were identified for the lot or product.Review of the dhr and supporting documentation showed no evidence of issues present that would have an association with this malfunction of tampon performance.The investigation revealed no issues that would require corrective action for the product manufactured.

Manufacturer Narrative

An investigation was conducted that included a 24-month trend analysis, product risk documentation, review of the dhr and supporting documentation.No trends were identified for the lot or product.Review of the dhr and supporting documentation showed no evidence of issues present that would have an association with this malfunction of tampon performance.The investigation revealed no issues that would require corrective action for the product manufactured.

Event Description

Having this product removed in pieces, doctor removed it, it came out in pieces, string frayed apart [device breakage] string was completely sucked up inside.And covered in blood; tampon stuck x 8 hours [foreign body in reproductive tract].Much discomfort (cried the entire time) [discomfort].Vagina: tenderness [and bleeding] present [vulvovaginal pain].Vagina: [tenderness and] bleeding present; vaginal bleeding (normal menstrual cycle) [vaginal haemorrhage] menstrual problem [menstrual disorder].Case narrative: on 04-feb-2023, a spontaneous report was received from a consumer regarding a 16-year-old female who was using playtex sport plastic, unscented (tampon, menstrual, unscented).On 07-feb-2023, additional information was received from a consumer.On 30-mar-2023, additional information was received from anonymous reporter.On 30-mar-2023, additional information was received from medical records.Medical history and concomitant products were not reported.On an unspecified date, the patient started use with playtex sport plastic, unscented.On (b)(6) 2023, after inserting the product and having the product inserted for at least 12 hours, the consumer tried to remove the product.The string frayed apart and was completely sucked up inside and covered in blood, and the product was stuck.The consumer's mother took her to their local urgent care center and the physician removed the tampon which came out in pieces and flushed the consumer with saline solution to ensure that no particles were left inside the consumer.The consumer took over-the-counter ibuprofen for cramps.As of 07-feb-2023, the status of product use was not reported, and the consumer was recovered and well.No additional information was provided.On 30-mar-2023, it was learned that on an unspecified date in (b)(6) 2023 (reported as on 03-feb-2023; previously reported as 02-feb-2023), the patient tried to remove the product before bed, but the string could not be located.The consumer did not know what to do and went to bed.The next morning, the consumer told her mother who promptly took her to the urgent care.It took several minutes to remove the product with forceps followed by irrigation.Pieces broke off and were removed individually.Bits were also present in the irrigated fluid.The patient cried the entire time, and she experienced much discomfort.It was previously reported consumer had subsequently recovered and was well.No additional information was provided.On 30-mar-2023, it was learned that, on (b)(6) 2023, the patient presented to the clinic with concerns of a tampon that she couldn't get out for 8 hours.She couldn't feel the string.She had been able to grab the corners of it, but it kept falling apart.She couldn't get it completely out.During her review of systems, the patient was positive for menstrual problem (not further clarified) and vaginal bleeding (normal menstrual cycle).During her physical exam, it was noted that a foreign body was present as well as vaginal tenderness and bleeding.The patient was placed in a lithotomy position and a speculum was used with the use of lubricant.The cotton foreign body was easily visualized.It was removed with circular forceps.Several attempts needed to be made due to disintegration of the foreign body.The foreign body was completely removed, and the surrounding tissue was irrigated with approximately 20 cc of normal saline.The patient tolerated the procedure without extra bleeding outside of her menstrual cycle.It was discussed that the patient should use strictly exterior pads until her menstrual cycle was completely over.No additional information was provided.

• Brand Name: PLAYTEX SPORT PLASTIC, UNSCENTED
• 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: 16491746
• MDR Text Key: 310771798
• Report Number: 2515444-2023-00008
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2024

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 Lot Number: 22271CA
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/26/2023; 01/10/2024
• 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: 16 YR
• Patient Sex: Female
• Patient Weight: 51 KG