FDA.reportPublic FDA data

MAUDE MDR 6788706

MDR report key
6788706
Report number
1722028-2017-00321
Event key
0
Event type
3
Date of event
2016-10-21
Date received
2017-08-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STEVE KERN
Address
10810 W. COLLINS AVE LAKEWOOD CO 80215 US
Phone
303-303-3032
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0HARVEST TERUMOAPC-20 PROCEDURE PACKTERUMO BCTFMF5140209Z9940R R
1HARVEST TERUMOAPC-20 PROCEDURE PACKTERUMO BCTJQC5140209Z9940R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-1101. R

Event Narratives#

N

Patient 1

ADDITIONAL PRODUCT CODE: FMF INVESTIGATION: PER THE CUSTOMER, THE PATIENT WAS GIVEN ANTIBIOTICS PROPHETICALLY PRIOR TO SURGERY. DURING THE PROCEDURE, BLOOD WAS COLLECTED AND PROCESSED, THEN ADMINISTERED TO THE PATIENT WITHOUT ISSUE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

D

Patient 1

THE CUSTOMER CALLED TO REPORT THAT A PATIENT UNDERWENT A DENTAL IMPLANT SURGERY ON (B)(6) 2016 AND WAS TREATED WITH PLATELET RICH PLASMA (PRP) PRODUCT. APPROXIMATELY ONE WEEK POST PROCEDURE, THE PATIENT DEVELOPED PAINFUL SWELLING, EXUDATE AND REDNESS IN THE JAW CLOSE TO THE IMPLANT. THE PATIENT RE-VISITED THE PHYSICIAN AT THE CUSTOMER'S SITE. PER PHYSICIAN'S ORDER, THE PATIENT WAS GIVEN ORAL ANTIBIOTICS FOR SEVERAL WEEKS AND WAS RELEASED FROM PHYSICIAN CARE. THE CUSTOMER REPORTS THAT THE PATIENT IS IMPROVING AND IN HEALTHY CONDITION. THE CUSTOMER DECLINED TO PROVIDE PATIENT'S WEIGHT.