MAUDE report

MAUDE report 29080: STENT CATHETER

Malfunction · received Dec 27, 1995 · JOHNSON & JOHNSON PRODUCTS

Key facts

MDR report key 29080
Report number MW1008004
Event type Malfunction
Brand name STENT CATHETER
Catalog number PS1530
Manufacturer JOHNSON & JOHNSON PRODUCTS
Product code MAF
Device class Class III
Date received by FDA Dec 27, 1995
Report date Dec 15, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ 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
  • No Adverse event flagged
  • Yes 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:

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