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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDGEWELL PERSONAL CARE PLAYTEX SPORT PLASTIC, UNSCENTED; TAMPON, MENSTRUAL, UNSCENTED
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EDGEWELL PERSONAL CARE PLAYTEX SPORT PLASTIC, UNSCENTED; TAMPON, MENSTRUAL, UNSCENTED Back to Search Results
Model Number K060981
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/29/2021
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
Issues with the tampons coming apart; the tampon fell apart [device breakage] some of the pieces of it are still inside of me; leaving pieces in my body [foreign body in reproductive tract].Case narrative: on 30-jun-2021, a spontaneous report was received from a consumer regarding a female of unreported age who was using playtex sport plastic, unscented (tampon, menstrual, unscented).On 02-jul-2021, additional information was received, and based on the information provided, the case was assessed as reportable.Medical history and concomitant products were not reported.On an unspecified date, the consumer started use of playtex sport plastic, unscented.On (b)(6) 2021, after starting the product, the consumer experienced issues with the tampons coming apart.When she attempted to remove the tampon from her body, the tampon fell apart, and some of the pieces were still inside her.Subsequently, the consumer was seen by a doctor, but no additional fibers were found.As of 02-jul-2021, the status of product use was not reported.No additional information was provided.
 
Event Description
On 30-jun-2021, a spontaneous report was received from a consumer regarding a female of unreported age who was using playtex sport plastic, unscented (tampon, menstrual, unscented).On 02-jul-2021, additional information was received, and based on the information provided, the case was assessed as reportable.On 02-sep-2021, the case was resubmitted to clarify this is a 30-day report.On 08-oct-2021, additional information was received from a consumer.Medical history and concomitant products were not reported.On an unspecified date, the consumer started use of playtex sport plastic, unscented.On (b)(6) 2021, after starting the product, the consumer experienced issues with the tampons coming apart.When she attempted to remove the tampon from her body, the tampon fell apart, and some of the pieces were still inside her.Subsequently, the consumer was seen by a doctor, but no additional fibers were found.As of 02-jul-2021, the status of product use was not reported.No additional information was provided.On 08-oct-2021, it was learned that on (b)(6) 2021, after removal of the tampon, the consumer went to a swimming pool, and she noticed when she got out that fibers were in her bathing suit.She saw a doctor, and no fibers were remaining inside her body (previously reported).No additional information was provided.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.
 
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.
 
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Brand Name
PLAYTEX SPORT PLASTIC, UNSCENTED
Type of Device
TAMPON, MENSTRUAL, UNSCENTED
Manufacturer (Section D)
EDGEWELL PERSONAL CARE
6 research drive
shelton CT 06484
Manufacturer (Section G)
EDGEWELL PERSONAL CARE
Manufacturer Contact
6 research drive
shelton 
MDR Report Key12246069
MDR Text Key264096533
Report Number2515444-2021-00016
Device Sequence Number1
Product Code HEB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K060981
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberK060981
Device Lot Number21077AE
Date Manufacturer Received10/08/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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