K111881

Substantially Equivalent

VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT

Applicant: Coloplast A/S
Product code: OTM
Advisory panel: General, Plastic Surgery
Date received: 2011-07-01
Decision date: 2011-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Adverse events under product code OTM

product code OTM

Injury: 760
Total: 760

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.