CURITY EYE PD 1-5/8X2-5/8 OVAL STRL
Received Feb 7, 2017 · Event occurred Jul 1, 2014
Report 1018120-2017-00021 · MDR key 6308835
Device
Product problems
- Material Integrity Problem
- Packaging Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD IS GENERATED FOR THE LOT OF THE PRODUCT MEETING ALL ACCEPTANCE CRITERIA PRIOR TO RELEASE. BY LOOKING AT THE SAMPLES IT LOOKS AS IF THE PRODUCT WAS NOT CUT CORRECTLY ON THE DIE THEREFORE IT WAS LEFT OBLONG, WHICH CAUSED IT TO GET CAUGHT IN THE SEALING SECTION OF THE PACKAGE. WITH THIS BEING A LOW TRENDING ISSUE, THERE WILL NOT BE ANY FORMAL CORRECTIVE ACTION/PREVENTATIVE ACTION AT THIS TIME. THIS REPORTED CONDITION WILL BE USED FOR TRENDING PURPOSES.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH AN EYE GAUZE PAD. THE CUSTOMER STATES: PRIOR TO USE ON A PATIENT, THE PAD WAS SEALED WITH PACKAGE. NO PATIENT INVOLVEMENT.