LAP SAC UNK

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 2003-07-29 for LAP SAC UNK manufactured by Cook Urological, Inc..

Event Text Entries

[323113] The doctor performed a nephrectomy. He had failed to remove the bag before closing the incision.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825146-2003-00008
MDR Report Key474649
Report Source00
Date Received2003-07-29
Date Mfgr Received2003-07-10
Date Added to Maude2003-08-01
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 Location0
Manufacturer Street1100 WEST MORGAN STREET
Manufacturer CitySPENCER IN 47460
Manufacturer CountryUS
Manufacturer Postal47460
Manufacturer Phone3128294891
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLAP SAC
Generic NameSURGICAL TISSUE POUCH
Product CodeKGY
Date Received2003-07-29
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key463512
ManufacturerCOOK UROLOGICAL, INC.
Manufacturer Address1100 WEST MORGAN ST. SPENCER IN 47460 US


Patients

Patient NumberTreatmentOutcomeDate
10 2003-07-29

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