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Adverse Event Report

DATASCOPE CORP. INSERTION KIT   back to search results
Device Problem Performance
Event Type  Death   Patient Outcome  Death;
Event Description

The new 8 fr. Sheath "collapsed like an accordion". The sheath was not returned to datascope for evaluation. The sheath was discarded by the facility. The patient went on to expire and the facility is attributing the event to the death.

 
Manufacturer Narrative

The sheath was discarded by the facility.

 
Search Alerts/Recalls

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Brand NameINSERTION KIT
Type of DeviceINSERTION KIT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DATASCOPE CORP.
15 law dr.
fairfield NJ 07004
Manufacturer (Section D)
DATASCOPE CORP.
15 law dr.
fairfield NJ 07004
Manufacturer Contact
whitney torning, director
15 law drive
fairfield , NJ 07004
(973) 244 -6136
Device Event Key319484
MDR Report Key330120
Event Key310676
Report Number2248146-2001-00012
Device Sequence Number1
Product CodeDYB
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 04/02/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Date Manufacturer Received04/02/2001
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?
Type of Device Usage Initial

Database last updated on February 28, 2009

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