InjuryNPK
MEMBRAGEL
Received Jun 21, 2010 · Event occurred Apr 3, 2010
Report 1222315-2010-00007 · MDR key 1732816
Device
Product problems
- Extrusion
Patient
58 YR
- Abscess
- Unspecified Infection
- Skin Inflammation
Narrative
Description of Event or Problem
CLINICIAN REPORTS THAT HE TREATED PT WITH MEMBRAGEL OVER STRAUMANN ALLOGRAFT, AROUND AN IMPLANT. THE TISSUE FACIAL TO THE GRAFT WAS INFLAMED AT ONE WEEK AND AT 2 WEEKS WAS ABSCESSED/INFECTED. HE STATED HE PUSHED ON THE TISSUE FACIAL TO THE IMPLANT AND THE MEMBRAGEL EXFOLIATED OUT THROUGH THE SULCUS. HE SAW HER AT 3 WEEKS AND SHE WAS DOING FINE.
Additional Manufacturer Narrative
MANUFACTURER COMPLETED A REVIEW OF THE MANUFACTURING RECORDS AND FOUND THE PRODUCT TO BE WITHIN SPECIFICATION.