K852091

Substantially Equivalent

ALBA DRY BURN PAD

Applicant
Alba-Waldensian, Inc.
Product code
NAD
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Valdese, NC, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code NAD

product code NAD
Injury
431
Malfunction
11,935
Other
1
Total
12,367

Source: openFDA MAUDE database, through . 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.