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

Model Number 078300117339

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/25/2021

Event Type  malfunction  

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

String broke [device breakage].Tampon kept breaking in pieces [device material issue].Could not get it [tampon] out [foreign body in reproductive tract].Case narrative: on 17-jan-2022, a spontaneous report was received from a consumer regarding a (b)(6) female who was using playtex sport plastic, unscented (tampon, menstrual, unscented).Medical history and concomitant products were not reported.On an unreported date, the consumer started use of playtex sport plastic, unscented.On (b)(6) 2021, after inserting the product, the string broke off, further described as a clean break, and the consumer could not get it out.She tried removing it herself, but pieces of the tampon kept breaking off, and she couldn't get it out.She was taken to the er (emergency room), and on the morning of (b)(6) 2021, "they removed everything." as of (b)(6) 2022, the status of product use was not reported.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.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

On 17-jan-2022, a spontaneous report was received from a consumer regarding a 25-year-old female who was using playtex sport plastic, unscented (tampon, menstrual, unscented).On 15-jun-2022, additional information was received in the form of medical records, and an unspecified iud (intrauterine device) was added as a co-suspect.Medical history and concomitant products were not reported.On an unreported date, the consumer started use of playtex sport plastic, unscented.On (b)(6) 2021, after inserting the product, the string broke off, further described as a clean break, and the consumer could not get it out.She tried removing it herself, but pieces of the tampon kept breaking off, and she couldn't get it out.She was taken to the er (emergency room), and on the morning of (b)(6) 2021, "they removed everything." as of (b)(6) 2022, the status of product use was not reported.No additional information was provided.On 15-jun-2022, it was learned patient was white and of jewish ethnicity.Medical history included anxiety, a tonsillectomy, an adenoidectomy, seasonal allergies (unconfirmed), covid vaccination, and a covid booster ((b)(6) 2021).Additional medical history was reported as "no past medical history." concomitant products included sertraline at 200 mg, 1x/day.On an unspecified date, the patient had an iud inserted.On (b)(6) 2021, the patient's period started which was unusual for her as she had an iud.At approximately 2200, on (b)(6) 2021, the patient tried to remove the tampon, and the string broke in the process.As a result, the tampon was stuck, and she was unable to remove it.In the early morning of (b)(6) 2021, she presented to the er.The reason for visit was reported as heavy vaginal bleeding and unable to remove tampon.She was having dark red vaginal bleeding with clots and had gone through 10 pads since trying to remove the tampon.She was concerned that this had something to do with her iud (not further clarified).At 00:14 on (b)(6) 2021, an initial temperature reading was 37.2 (temporal), and at 00:17, an initial sepsis screen was negative.While in the waiting room, the patient developed chills, body aches, and a fever.At 04:30, a sepsis screen tool resulted in a positive screen, and an infection was suspected.An iv (intra-venous) line was established to the right forearm, and a 1st set of bcx (blood cultures) were drawn at time of placement of iv site.Urine was collected by straight cath (catheter), and a specimen was obtained for culture.Lab results reported as high for neutrophils 84 (%; 41-73) and low lymphocytes 8 (%; 16-43) were reported.At 4:20, the patient was given iv fluids of sodium chloride 0.9% at 1000 ml/hour.At 4:50, the patient was given 975 mg of tylenol (acetaminophen) orally.At 05:44, the patient had a pelvic exam, and the tampon was removed.The pelvic exam showed no gross vaginal bleeding, and she tolerated the exam well.At 6:10, the covid test came back with a positive result.At 06:30, a second set of bcx were obtained and sent to lab.At 6:40, the patient was given iv fluids of sodium chloride 0.9% at 1000 ml/hour (patient received aggressive hydration with a total of 2000 ccs of nss (normal saline solution) was given.At 6:30, her temperature decreased.At re-evaluation at 7:30, the patient's condition had stabilized, and from then on her condition was stable.At 07:41, the pain medication was ordered, and the patient was given ketorolac injection at 30 mg via iv push.At 9:35, the patient was discharged, and her condition was reported as improved.She was given discharge instructions for viral syndrome (adult) and foreign body vaginal (adult) and was advised to follow-up with her primary care provider in 1 to 2 days and to return to the er if the pain was worse.She was advised to take tylenol or advil (ibuprofen) for pain, and fluids were encouraged.The final diagnoses were covid and vaginal fb (foreign body).On (b)(6) 2021, the urine culture's final resulted showed a colony count of >100,000 cfu/ml of lactobacillus species (reference range not reported).On (b)(6) 2021, both blood cultures showed no growth after 5 days (final result).As of (b)(6) 2022, the iud was still inserted, the outcome of covid was improved, and the outcome of the heavy vaginal bleeding was not reported.No additional information was provided.

• Brand Name: PLAYTEX SPORT PLASTIC, UNSCENTED
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): EDGEWELL PERSONAL CARE; 6 research drive; shelton CT
• Manufacturer (Section G): EDGEWELL PERSONAL CARE
• Manufacturer Contact: 6 research drive; shelton, CT
• MDR Report Key: 13537792
• MDR Text Key: 288380706
• Report Number: 2515444-2022-00006
• 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
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 078300117339
• Device Lot Number: 21113X
• Date Manufacturer Received: 06/15/2022
• 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
• Treatment: IUD (INTRAUTERINE DEVICE).; ZOLOFT (SERTRALINE HYDROCHLORIDE).
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 53 KG