MAUDE manufacturer profile

CALDERA MEDICAL INC. · PWJ

MAUDE profile for Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

Key facts

Manufacturer CALDERA MEDICAL INC.
Manufacturer group CALDER MEDICAL SARL-NAUCHATEL
Product code PWJ
Product code name Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Pain, No Clinical Signs, Symptoms or Conditions, Patient-Device Incompatibility, Hyperplasia, Swelling/ Edema, Sexual Dysfunction, Unspecified Nervous System Problem, Adverse Event Without Identified Device or Use Problem 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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