VISCERA RETAINER 3202

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-08-19 for VISCERA RETAINER 3202 manufactured by Adept-med Intl., Inc..

Event Text Entries

[16479245] In 2004 received telephone call from lab conducting product testing which drew the sterility of the product into question.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2918699-2004-00007
MDR Report Key540061
Report Source00
Date Received2004-08-19
Date of Report2004-08-19
Date of Event2004-08-13
Date Mfgr Received2004-08-13
Device Manufacturer Date2004-03-01
Date Added to Maude2004-08-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer Street665 PLEASANT VALLET RD.
Manufacturer CityDIAMOND SPRINGS CA 95619
Manufacturer CountryUS
Manufacturer Postal95619
Manufacturer Phone9499533110
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVISCERA RETAINER
Generic NameVISCERA RETAINER
Product CodeGCZ
Date Received2004-08-19
Model Number3202
Catalog Number3202
Lot Number1204
ID NumberNA
Device Expiration Date2006-01-30
OperatorOTHER
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key529370
ManufacturerADEPT-MED INTL., INC.
Manufacturer Address* DIAMOND SPRINGS CA 95619 US
Baseline Brand NameVISCERA RETAINER
Baseline Generic NameVICERA RETAINER
Baseline Model No3202
Baseline Catalog No3202
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2004-08-19

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