OPTIMESH DEPOLYABLE GRAFT CONTAINMENT DEVICE
Received Oct 28, 2018 · Event occurred Oct 3, 2018
Report 2135156-2018-00007 · MDR key 8011741
Device
Product problems
- Migration
- Migration
Patient
67 YR
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
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