FDA.reportPublic FDA data

MAUDE MDR 7053086

MDR report key
7053086
Report number
1722028-2017-00454
Event key
0
Event type
3
Date of event
2017-10-25
Date received
2017-11-22
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 120-01, BONE MARROW ASPIRATE CONCENTRATE PROCEDUTERUMO BCTJQC5142311Z9949R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-2201. 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 10/01/2017. THE PROCEDURE WAS PERFORMED ON (B)(6) 2017. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. PATIENT WEIGHT IS NOT AVAILABLE AT THIS TIME. PATIENT OUTCOME IS NOT AVAILABLE AT THIS TIME. THE BMAC DISPOSABLES SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.