MAUDE report

MAUDE report 42011: BLAKE ROUND SILICONE HUBLESS DRAINS

Malfunction · received Sep 27, 1996 · JOHNSON & JOHNSON MEDICAL, INC.

Key facts

MDR report key 42011
Report number 1618732-1996-00009
Event type Malfunction
Brand name BLAKE ROUND SILICONE HUBLESS DRAINS
Catalog number 2227
Manufacturer JOHNSON & JOHNSON MEDICAL, INC.
Product code GCY
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Sep 27, 1996
Report date Aug 28, 1996
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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