ALWAYS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-12 for ALWAYS * manufactured by Procter & Gamble.

Event Text Entries

[19260539] Product is a single wrapped item. Complainant opened individual package and noticed something in the "shell" of the sanitary pad. Initially thought it looked like a "rat dropping" and contacted the environmental health svs in their co. Object was later identified as "fly pulpa case". Complainant stopped using product in 02/2001.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002948
MDR Report Key320150
Date Received2001-03-12
Date of Report2001-02-26
Date of Event2001-02-01
Date Added to Maude2001-03-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameALWAYS
Generic NameSANITARY PAD, OVERNIGHT
Product CodeHHL
Date Received2001-03-12
Model NumberNA
Catalog Number*
Lot Number0314CA11671537
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key309674
ManufacturerPROCTER & GAMBLE
Manufacturer Address1 PROCTER & GAMBLE PLAZA CINCINNATI OH 45202 US


Patients

Patient NumberTreatmentOutcomeDate
10 2001-03-12

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