K070653

Substantially Equivalent

KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662

Applicant: Tyco Healthcare
Product code: FRO
Advisory panel: Unknown
Date received: 2007-03-09
Decision date: 2007-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, 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.