K003402
Substantially EquivalentWELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
- Applicant
- Welcon, Inc.
- Product code
- JOL
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ayer, MA, US
Adverse events under product code JOL
product code JOL- Death
- 7
- Injury
- 177
- Malfunction
- 1,306
- Other
- 1
- Total
- 1,491
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.