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Adverse Event Report

ALLEGIANCE HEALTHCARE CORP ALLEGIANCE JACKSON PRATT 10FR (1/8") SILICONE ROUND DRAIN   back to search results
Catalog Number SU130-1321
Device Problem Tip breakage
Event Date 08/21/2000
Patient Outcome  Other;
Event Description

Tip of jackson pratt broke off when md removing it from pt.

 
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Brand NameALLEGIANCE
Type of DeviceJACKSON PRATT 10FR (1/8") SILICONE ROUND DRAIN
Baseline Brand NameWOUND DRAIN
Baseline Generic NameWOUND DRAIN
Baseline Catalogue NumberSU130-1321
Baseline Model NumberSU130-1321
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALLEGIANCE HEALTHCARE CORP
1500 waukegan rd
mcgaw park IL 60085
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE CORP.
mcgaw park IL 60085
Device Event Key289878
MDR Report Key299479
Event Key281347
Report Number299479
Device Sequence Number1
Product CodeGCY
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 08/25/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSU130-1321
Device LOT Number1000075
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/21/2000
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer08/25/2000
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on January 30, 2009

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