XCM BIOLOGIC
Received Jul 12, 2017 · Event occurred Jun 7, 2017
Report 2530154-2017-00003 · MDR key 6708273
Device
Generic name
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Manufacturer
Dsm BiomedicalModel number
30012-XXProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Reaction
- Reaction
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED AND NO ADDITIONAL INFORMATION WAS RECEIVED. NO LOT NUMBER WAS PROVIDED, THEREFORE NO DEVICE HISTORY RECORD REVIEW WAS PERFORMED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT RECEIVED AN XCM BIOLOGIC DEVICE ON THE (B)(6) 2017. THERE IS NO DEMOGRAPHIC INFORMATION ABOUT THE PATIENT AVAILABLE, NOR IS THERE ANY INFORMATION ABOUT THE TYPE OF PROCEDURE WHICH WAS PERFORMED. IT WAS DISCOVERED ON THE (B)(6) 2017 THAT THERE WAS A "REJECTION REACTION AFTER USE ON THE PATIENT". ADDITIONAL INFORMATION HAS BEEN REQUESTED NUMEROUS TIMES BUT NO FURTHER INFORMATION IS AVAILABLE AS OF THE DATE OF THIS REPORT.