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Adverse Event Report

PROFESSIONAL DISPOSABLES, INC. POVIDONE-IODINE SCRUBSTICKS   back to search results
Model Number NA (SOAP + BETADINE)
Device Problem Contamination, bacterial
Event Date 04/19/1999
Event Description

Post-transfusion (unit of platelets, pheresis; 4 days from collection) reaction of hives, malaise with chills and rigors; temp went from 99. 2 f to 105. 2 f. Conclusion - bacteremic transfusion reaction, coupled with a mild allergic/urticarial transfusion reaction.

 
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Brand NamePOVIDONE-IODINE SCRUBSTICKS
Type of DevicePOVIDONE-IODINE SCRUBSTICKS
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
PROFESSIONAL DISPOSABLES, INC.
two nice pak park
orangeberg NY 10962 1376
Device Event Key214840
MDR Report Key221541
Event Key207869
Report Number221541
Device Sequence Number4
Product CodeKOY
Report Source User Facility
Reporter Occupation Invalid Data
Type of Report Initial
Report Date 04/26/1999
5 DeviceS WERE Involved in the Event:1 2 3 4 5 
1 Patient Was Involved in the Event
Date FDA Received04/30/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date05/01/2000
Device MODEL NumberNA (SOAP + BETADINE)
Device Catalogue NumberS82125
Device LOT Number8015778
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/27/1999
Distributor Facility Aware Date04/19/1999
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer04/23/1999
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on December 31, 2008

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