MalfunctionOXJ
SYMBOTEX COMPOSITE MESH/20*15 CM, BOX OF 1
Received Feb 16, 2017
Report 9615742-2017-00023 · MDR key 6335415
Device
Generic name
Mesh, Surgical, Non-absorbable, Large Abdominal Wall Defects
Manufacturer
Sofradim ProductionModel number
SYM2015Catalog number
SYM2015
Lot number
PQC0574X
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
ACCORDING TO THE REPORTER: DURING THE PLACEMENT OF THE MESH ON THE PATIENT, THE SURGEON OBSERVED THAT THEY WERE LEFT SMALL PIECES OF COLLAGEN IN THE GLOVE. THERE WAS NO PATIENT HARM.