K112936

Substantially Equivalent

SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM

Applicant: Rexam Consummer Plastics Inc.D/B/A Rexam Pharma
Product code: MEG
Advisory panel: General Hospital
Date received: 2011-10-03
Decision date: 2012-01-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Buffalo Grove, IL, US

Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.