510(k) K113312— HY-CHLO(TM)WOUND SCRUB

Substantially Equivalent

Patrin Pharma

Clearance details

Applicant: Patrin Pharma
Product code: Code FQH
Advisory panel: General Hospital
Date received: 2011-11-09
Decision date: 2012-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, US

Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

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.