inforMED
OTKClass II

Wound Drain Catheter System

General, Plastic Surgery · 21 CFR 878.4780

For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.

MDR events34All time
Recalls0All time
Registered firms8Currently listed
510(k) clearances7All time

Recent MDR events

34 adverse event reports on file

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Event type breakdown

Malfunction29
Injury4
Death1

Most-reported manufacturers

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Degania Silicone Ltd17Clearflow, Inc.10Clearflow Inc3Cardinal Health 200 Llc1Clearflow, Inc1Unknown1Xeridiem1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

8 firms currently registered for this product code

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510(k) clearances

7 clearances for this product code

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