K011117

Substantially Equivalent

MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS

Applicant: Mps Acacia
Product code: MEB
Advisory panel: General Hospital
Date received: 2001-04-12
Decision date: 2001-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.