MAUDE manufacturer profile

MDT SOFAMOR DANEK PUERTO RICO MFG · EZW

MAUDE profile for Stimulator, Electrical, Implantable, For Incontinence

Key facts

Manufacturer MDT SOFAMOR DANEK PUERTO RICO MFG
Manufacturer group MDT SOFAMOR DANEK PUERTO RICO MFG
Product code EZW
Product code name Stimulator, Electrical, Implantable, For Incontinence

At a glance

  • 100–999 MAUDE reports
  • 100–999 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Device Operates Differently Than Expected, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Pain, Therapeutic Effects, Unexpected, Complaint, Ill-Defined, Insufficient Information, Inappropriate/Inadequate Shock/Stimulation 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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