PLAYTEX SPORT, MULTIPACK, 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 2010-09-17 for PLAYTEX SPORT, MULTIPACK, SCENTED TAMPONS manufactured by Playtex Products, Inc..

Event Text Entries

[1662384] Received a report from a consumer indicating she sought a medical examination for cramping and discomfort several weeks after the end of her last menses. Consumer indicated her physician removed a piece of a tampon pledget without incident, and she has since fully recovered.
Patient Sequence No: 1, Text Type: D, B5


[8704505] We have requested and await the consumer's return of product for evaluation and date code information for investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2515444-2010-00006
MDR Report Key1845885
Report Source07
Date Received2010-09-17
Date of Report2010-09-17
Date of Event2010-08-01
Date Mfgr Received2010-08-20
Date Added to Maude2010-09-30
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 DRIVE
Manufacturer CityALLENDALE NJ 07401
Manufacturer CountryUS
Manufacturer Postal07401
Manufacturer Phone2017858000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePLAYTEX SPORT, MULTIPACK, SCENTED TAMPONS
Generic NameTAMPON
Product CodeHIL
Date Received2010-09-17
Model NumberNA
Catalog NumberNA
Lot NumberUNK
ID NumberNA
OperatorLAY USER/PATIENT
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPLAYTEX PRODUCTS, INC.
Manufacturer Address804 WALKER ROAD DOVER DE 19990 US 19990


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2010-09-17

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