MAUDE manufacturer profile

PROGENIKA BIOPHARMA, S.A · PEP

MAUDE profile for Molecular Erythrocyte Typing Test

Key facts

Manufacturer PROGENIKA BIOPHARMA, S.A
Manufacturer group PROGENIKA BIOPHARMA, S.A
Product code PEP
Product code name Molecular Erythrocyte Typing Test

At a glance

  • 100–999 MAUDE reports
  • 100–999 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, False Positive Result, False Negative Result, No Consequences Or Impact To Patient, Incorrect, Inadequate or Imprecise Result or Readings, Patient Problem/Medical Problem, Insufficient Information, No Apparent Adverse Event 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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