K100218

Substantially Equivalent

BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM

Applicant: Coloplast A/S
Product code: FRO
Advisory panel: Unknown
Date received: 2010-01-26
Decision date: 2010-02-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

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.