K061409

Substantially Equivalent

SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET

Applicant: Precise Medical Products, Ltd.
Product code: MEB
Advisory panel: General Hospital
Date received: 2006-05-22
Decision date: 2006-06-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Shlomi, IL

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.