MAUDE brand profile
INTEGRITY AFX DR PKGDSTER MODEL 5346
MAUDE brand safety profile
Key facts
| Brand name | INTEGRITY AFX DR PKGDSTER MODEL 5346 |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Pacemaker Found in Back-Up Mode, Mechanical Problem, Failure to Interrogate, Inappropriate or Unexpected Reset, Difficult to Remove, Failure to Disconnect, Premature Discharge of Battery Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1