MAUDE report

MAUDE report 11853: SYNCHROMED

Injury · received Feb 15, 1994 · SYNCHROMED CORPORATION

Key facts

MDR report key 11853
Report number 11853
Event type Injury
Brand name SYNCHROMED
Model number 8611-H
Catalog number SJ 1203687R
Manufacturer SYNCHROMED CORPORATION
Product code MEA
Device class Class II
Date received by FDA Feb 15, 1994
Report date Jan 5, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1,000+ MAUDE reports for this brand
  • 100–999 Death reports for this brand
  • 1,000+ Injury reports for this brand
  • Yes 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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