ALLERGAN CUP (GORETEX) NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2000-01-28 for ALLERGAN CUP (GORETEX) NI manufactured by Allergan.

Event Text Entries

[18448571] The mfr of a contact lens care cup for use with 3% hydrogen peroxide systems received a report from another country that a cup burst during use. No injury occurred. The mfr is investigating.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2011068-1999-00017
MDR Report Key260600
Report Source01,04
Date Received2000-01-28
Date of Report1999-11-25
Date Mfgr Received1999-11-25
Date Added to Maude2000-02-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE GARBE
Manufacturer Street2525 DUPONT DRIVE P.O. BOX 19534
Manufacturer CityIRVINE CA 926239534
Manufacturer CountryUS
Manufacturer Postal926239534
Manufacturer Phone7142464285
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALLERGAN CUP (GORETEX)
Generic NameCONTACT LENS CARE PRODUCT
Product CodeHRD
Date Received2000-01-28
Returned To Mfg1999-11-26
Model NumberNI
Catalog NumberNI
Lot NumberUNK
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedI
Device Sequence No1
Device Event Key252407
ManufacturerALLERGAN
Manufacturer Address2525 DUPONT DR. P.O. BOX 19534 IRVINE CA 926239534 US


Patients

Patient NumberTreatmentOutcomeDate
13 2000-01-28

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