MalfunctionHCI
L-CLIP PERM BAYONET 7 MM
Received Dec 18, 2013
Report 1045834-2013-16099 · MDR key 3981072
Device
Product problems
- Inadequate Instructions for Healthcare Professional
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RECEIVED BY (B)(4). (B)(4) IS THE IMPORTER OF THE DEVICE. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem
REPORT RECEIVED FROM THE USA STATING THAT "PACKAGE LABELED AS A 45.748 ACTUALLY CONTAINS 45.744." THE DEVICE WAS NOT BEING USED DURING SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. THE DATE OF EVENT IS UNK. THERE WAS NO ADDITIONAL INFO PROVIDED.