LYOPLANT ONLAY 7.5X7.5CM
Received Oct 12, 2017 · Event occurred Sep 7, 2017
Report 9610612-2017-00494 · MDR key 6944053
Device
Generic name
Lyoplant Onlay
Manufacturer
Aesculap AgModel number
1067040Catalog number
1067040
Lot number
216475
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Fluid Discharge
- Fluid Discharge
Narrative
Additional Manufacturer Narrative
THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. BASED ON THE DEVICE HISTORY REPORT AND THE QUALITY STANDARDS, WE CAN EXCLUDE A MANUFACTURING OR MATERIAL RELATED ERROR. NO CAUSALITY BETWEEN THE PRODUCT AND THE MENTIONED ISSUE CAN BE FOUND. A GRANULOMA OR SERUM CAN OCCUR, FOR EXAMPLE CAUSED BY AN ISSUE MANIPULATION DURING SURGERY OR AN IMPROPER USER TECHNIQUE. AN INFECTION OF THE PATIENT THAT ALREADY EXISTED BEFORE SURGERY CAN ALSO NOT BE EXCLUDED. NO CAPA IS NECESSARY.
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COUNTRY: USA. IT WAS REPORTED THAT AFTER A PATIENT HAD A GRADE I MENINGIOMA PROCEDURE, THE PATIENT HAD A RESECTION OF THE MENINGIOMA. LYOPLANT ONLAY WAS USED AT THE END OF THE SURGERY. MRI REVELED A SEROMA POST.