PLAYTEX GENTLE GLIDE, REGULAR, SCENTED TAMPONS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-02-02 for PLAYTEX GENTLE GLIDE, REGULAR, SCENTED TAMPONS manufactured by Playtex Products, Inc..

Event Text Entries

[22051122] We have requested and await consumer's return of product for evaluation. Lot code information advised by the reporter has been sent to qa for investigation. We await the results. Since reporter did not know which absorbancy was used during the described event, we have also submitted mfr report # 2515444201000001 for the other product.
Patient Sequence No: 1, Text Type: N, H10


[22123686] Received a report from a consumer indicating she recently gave birth, and has since experienced only a few irregular menstrual cycles; wherein both gentle glide regular and super absorbency tampons were used. Consumer reported on one occasion each during last two menses, she experienced pieces of a tampon pledget being left behind, and expelling several hours after, the removal of the tampon pledget. Consumer did not know which absorbancy tampon was used during said incidents. No injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2515444-2010-00002
MDR Report Key1615355
Report Source07
Date Received2010-02-02
Date of Report2010-02-01
Date of Event2009-12-01
Date Mfgr Received2010-01-05
Date Added to Maude2010-09-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJANET DEPALMA
Manufacturer Street75 COMMERCE DR
Manufacturer CityALLENDALE NJ 07401
Manufacturer CountryUS
Manufacturer Postal07401
Manufacturer Phone2017858000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePLAYTEX GENTLE GLIDE, REGULAR, SCENTED TAMPONS
Generic NameTAMPON
Product CodeHIL
Date Received2010-02-02
Model NumberNA
Catalog NumberNA
Lot Number09190BA
ID NumberNA
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPLAYTEX PRODUCTS, INC.
Manufacturer Address804 WALKER RD DOVER DE 19990 US 19990


Patients

Patient NumberTreatmentOutcomeDate
10 2010-02-02

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