GRAFTON GEL
Received Dec 5, 2011 · Event occurred Oct 27, 2011
Report 2246640-2011-00025 · MDR key 2362841
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Erythema
- Swelling
Narrative
Description of Event or Problem
ALLOGRAFT BONE VOID FILLER WAS INJECTED INTO THE HUMERAL BONE CYST OF A PEDIATRIC PT. THE DAY FOLLOWING THE PROCEDURE, THE PT PRESENTED WITH SIGNIFICANT SWELLING AND REDNESS AT THE INJECTION SITE. THE PT WAS GIVEN ANTIBIOTICS AND THE SYMPTOMS SUBSIDED SIGNIFICANTLY OVER THE COURSE OF ONE WEEK.
Additional Manufacturer Narrative
NO LOT INFO WAS PROVIDED BY THE HEALTHCARE PROFESSIONAL. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. THEREFORE A DEFINITIVE CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED. THE TREATING SURGEON REPORTED, HOWEVER, THAT HE WAS NOT CONCERNED ABOUT THE PRODUCT OR THE INITIAL INFLAMMATION AS THE SYMPTOMS SUBSIDED DRAMATICALLY OVER THE COURSE OF ONE WEEK.