InjuryNPK
MEMBRGEL
Received Oct 19, 2010 · Event occurred Jul 21, 2010
Report 1222315-2010-00014 · MDR key 1880290
Device
Product problems
- Insufficient Device Problem Information
Patient
56 YR
- Unspecified Infection
- Pain
- Swelling
Narrative
Description of Event or Problem
PT UNDERWENT A DENTAL TREATMENT ON (B)(6), 2010 WHERE MEMBRAGEL WAS USED. THE CLINICIAN REPORTS ON (B)(6), 2010 THAT PT PRESENTS WITH INFECTED AREAS 18 AND 19 WITH PAIN AND SWELLING. BAKING SODA RINSES, ANTIBIOTICS, PAIN MEDICATION, RINSE WITH PERIDEX ARE PRESCRIBED.
Additional Manufacturer Narrative
MFR COMPLETED A REVIEW OF THE MFG RECORDS AND FOUND THE PRODUCT TO BE WITHIN SPECIFICATION.