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Adverse Event Report

COOK, INC. CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET   back to search results
Catalog Number C-PTS-100
Event Date 12/09/1998
Event Type  Death  
Manufacturer Narrative

This event was reported to co from the user facility per medwatch report. Evaluation: no product was returned to assist in co's evaluation of this matter. Unfortunately, co is unable to determine why difficulty may have been encountered.

 
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Brand NameCIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
Type of DeviceINTRODUCER SET
Baseline Brand NameCIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER
Baseline Generic NameNA
Baseline Catalogue NumberC-PTS-100
Baseline Device FamilySPECIAL SETS
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Manufacturer (Section G)
COOK, INC.
750 daniels way po bx 489
bloomington IN 47402
Manufacturer Contact
rita harden
750 daniels way
bloomington , IN 47404
(812) 339 -2235 ext 2222
Device Event Key202137
MDR Report Key208261
Event Key195482
Report Number1820334-1999-00010
Device Sequence Number1
Product CodeBTO
Report Source Manufacturer
Source Type Health Professional,User facility
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/02/1999
Is This An Adverse Event Report? No
Device Catalogue NumberC-PTS-100
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received01/04/1999
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device? Unknown
Type of Device Usage Initial

Database last updated on February 28, 2009

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