MalfunctionGDZ
INTEGRA JARIT
Received Aug 13, 2024 · Event occurred Aug 6, 2024
Report 19971513 · MDR key 19971513
Device
Generic name
Handle, Scalpel
Manufacturer
Integra Lifesciences Production CorporationModel number
110178Catalog number
110-178
Lot number
AF2308
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
NEW INSTRUMENTS RECEIVED OUT OF THE PACKAGING WITH BROWN RUST LIKE STAINING AND BLACK SPOTS WHEN UNPACKAGED. THESE ARE BRAND NEW INSTRUMENTS OUT OF THE BOX PRIOR TO PROCESSING UPON ARRIVAL TO THE FACILITY.