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Adverse Event Report

BARD USCI USCI BARD - TEFLON COATED GUIDE WIRE .035" 145 CM. 3MM "J" MOVABLE CORE   back to search results
Catalog Number 007447
Event Date 09/14/1993
Patient Outcome  Other;
Event Description

No event description on this report device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: other. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was not destroyed/disposed of.

 
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Brand NameUSCI BARD - TEFLON COATED GUIDE WIRE .035" 145 CM. 3MM "J"
Type of DeviceMOVABLE CORE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD USCI
Manufacturer (Section D)
BARD USCI
Device Event Key7431
MDR Report Key7752
Event Key9722
Report Number7752
Device Sequence Number1
Product CodeDQX
Report Source User Facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 09/23/1993
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/04/1994
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number007447
Device LOT Number07GC1552
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Unknown
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/14/1993
Event Location Hospital
Date Report TO Manufacturer09/14/1993
Is the Device an Implant? No

Database last updated on January 06, 2009

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