DeviceClearance

K071371

Substantially Equivalent

COPA AMD ANTIMICROBIAL WOUND DRESSING

Applicant
Tyco Healthcare Group LP
Product code
FRO
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mansfield, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO
Death
30
Injury
653
Malfunction
479
Other
11
Total
1,173

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.