LIFESTYLES 600814/5500 3503 (ANSELL)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-25 for LIFESTYLES 600814/5500 3503 (ANSELL) manufactured by Ansell Healthcare Products Inc.

Event Text Entries

[16267493] Customer and pts complain of burning and skin irritation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1022476
MDR Report Key343923
Date Received2001-07-25
Date of Report2001-07-20
Date Added to Maude2001-07-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLIFESTYLES
Generic NameCONDOM W/SPERMICIDE
Product CodeLTZ
Date Received2001-07-25
Model Number600814/5500
Catalog Number3503 (ANSELL)
Lot Number0812948322
ID Number6515-01-266-3802
Device Expiration Date2002-08-01
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key333259
ManufacturerANSELL HEALTHCARE PRODUCTS INC
Manufacturer AddressINDUSTRIAL RD, PO BOX 1252 DOTHAN AL 36303 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2001-07-25

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