MAUDE manufacturer profile

BOSTON SCIENTIFIC CORPORATION · OVB

MAUDE profile for Hydrogel Spacer

Key facts

Manufacturer BOSTON SCIENTIFIC CORPORATION
Manufacturer group BOSTON SCIENTIFIC CORK LIMITED
Product code OVB
Product code name Hydrogel Spacer

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Positioning Problem, No Clinical Signs, Symptoms or Conditions, Pain, Adverse Event Without Identified Device or Use Problem, Discomfort, Abscess, Fistula, Inflammation Most reported problems

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

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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