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Adverse Event Report

ALLEGIANCE HEALTHCARE CORP. JACKSON-PRATT DRAIN   back to search results
Device Problem Device breakage
Event Date 10/15/2000
Patient Outcome  Other;
Event Description

When removing the jackson-pratt drain there was a break right at the intersection of the clear plastic tubing with the associated white tubing. Pt taken back to surgery to remove the remaining piece.

 
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Type of DeviceJACKSON-PRATT DRAIN
Baseline Brand NameJACKSON PRATT DRAIN
Baseline Generic NameWOUND DRAIN
Baseline Catalogue NumberUNK
Baseline Model NumberUNKJP
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
4551 philadelphia
onterio CA 91761
Device Event Key296788
MDR Report Key306702
Event Key288208
Report Number306702
Device Sequence Number1
Product CodeGCY
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/26/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2000
Is This An Adverse Event Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/26/2000
Distributor Facility Aware Date10/15/2000
Event Location Hospital
Date Report TO Manufacturer10/26/2000
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on January 30, 2009

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