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Adverse Event Report

ALLEGIANCE HEALTHCARE MINOR TRAY   back to search results
Model Number 05-0117
Event Date 11/03/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

"a pt with bilateral pseudomonas pneumonia on ventilator developed a left chest empyema. The physician attempted to place a chest tube in the left posteriolateral position. During this procedure, the surgical clamp broke and a large portion of the jaw of the clamp was deep in the soft tissue overlying the ribs. Pt was taken or o. R. To remove the fb and obtain surgical drainage of the empyema. The foreign body was laying posterior and through the latissimus muscle. The jaw of the clamp was found to be immediately overlying the ribs in the area. The foreign body was removed. The clamp was part of the minor procedure tray used for chest tube insertion and came packaged in the tray. The pt was discharged to home in 2002 with no untoward effects anticipated due to this incident.

 
Manufacturer Narrative

A sample was sent to the mfr of the clamp in 12/2002. Co is waiting for their investigation response. Additional info will be provided to the fda a soon as it comes in. Allegiance healthcare is filing as the mfr of the finished good.

 
Search Alerts/Recalls

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Brand NameMINOR TRAY
Type of DeviceMINOR TRAY
Baseline Brand NameMINOR TRAY
Baseline Generic NameMINOR TRAY
Baseline Catalogue Number05-0117
Baseline Model Number05-0117
Baseline Device FamilyPROCEDURE TRAY
Baseline Device 510(K) NumberK810242
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed04/15/1981
Manufacturer (Section F)
ALLEGIANCE HEALTHCARE
1500 waukegan rd
mcgaw park IL 60085
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE
1500 waukegan rd
mcgaw park IL 60085
Manufacturer Contact
patricia sharpe-gregg
1430 waukegan rd
mcgaw park , IL 60085
(847) 578 -4148
Device Event Key421888
MDR Report Key432930
Event Key409627
Report Number1423507-2002-00160
Device Sequence Number1
Product CodeFRL
Report Source Manufacturer
Source Type User facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/17/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number05-0117
Device Catalogue Number05-0117
Device LOT Number1098
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/12/2002
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/20/2002
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/01/2002
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on January 30, 2009

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