FDA.reportPublic FDA data

MAUDE MDR 7143829

MDR report key
7143829
Report number
1722028-2017-00514
Event key
0
Event type
3
Date of event
2017-11-03
Date received
2017-12-22
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
1HARVEST TERUMOBMAC2 30-02, BONE MARROW ASPIRATE CONCENTRATE PROCEDURTERUMO BCTJQC5142110Z9905R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-2201. O

Event Narratives#

N

Patient 1

ADDITIONAL PRODUCT CODE: FMF INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

D

Patient 1

UPON REVIEW OF THE INFORMATION PROVIDED BY THE DISTRIBUTOR, IT WAS DISCOVERED THAT AN EXPIRED BONE MARROW ASPIRATE CONCENTRATE (BMAC) DISPOSABLE WAS USED ON A PATIENT. THE BMAC DISPOSABLE SET WAS LABELED WITH AN EXPIRATION DATE OF 09/01/2017. THE PROCEDURE WAS PERFORMED ON (B)(6) 2017. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. THE CUSTOMER DECLINED TO PROVIDE PATIENT WEIGHT. THE BMAC DISPOSABLES SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.