MAUDE report

MAUDE report 14145: XYLENE AR

No Answer Provided · received Apr 25, 1994 · MALLINCKRODT SPECIALTY CHEMICAL COMPANY

Key facts

MDR report key 14145
Report number 1483039-1994-00010
Event type No Answer Provided
Brand name XYLENE AR
Catalog number 8668-20
Manufacturer MALLINCKRODT SPECIALTY CHEMICAL COMPANY
Product code ICF
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Apr 25, 1994
Report date Apr 18, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1–9 MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • None Injury reports for this brand
  • Yes Adverse event flagged
  • No Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

Browse all MAUDE medical device reports