K191460

Substantially Equivalent

PWD Platform Wound Dressing 3 x 5 Oblong

Applicant: Applied Tissue Technologies, LLC
Product code: OMP
Advisory panel: General, Plastic Surgery
Date received: 2019-06-03
Decision date: 2019-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Hingham, MA, US

Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

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.