K161289

Substantially Equivalent

DURAFIBER Ag

Applicant: Smith & Nephew Medical Limited
Product code: FRO
Advisory panel: Unknown
Date received: 2016-05-09
Decision date: 2016-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hull, GB

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.