HARVEST TERUMO 51402

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-11 for HARVEST TERUMO 51402 manufactured by Terumo Bct.

Event Text Entries

[82503901] 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.
Patient Sequence No: 1, Text Type: N, H10


[82503902] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1722028-2017-00321
MDR Report Key6788706
Report SourceHEALTH PROFESSIONAL
Date Received2017-08-11
Date of Report2017-08-11
Date of Event2016-10-21
Date Mfgr Received2017-11-07
Device Manufacturer Date2016-09-29
Date Added to Maude2017-08-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEVE KERN
Manufacturer Street10810 W. COLLINS AVE
Manufacturer CityLAKEWOOD CO 80215
Manufacturer CountryUS
Manufacturer Postal80215
Manufacturer Phone3032392246
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameHARVEST TERUMO
Generic NameAPC-20 PROCEDURE PACK
Product CodeFMF
Date Received2017-08-11
Returned To Mfg2017-07-28
Catalog Number51402
Lot Number09Z9940
ID Number05020583514027
Device Expiration Date2017-09-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerTERUMO BCT
Manufacturer AddressLAKEWOOD CO 80215 US 80215

Device Sequence Number: 1

Brand NameHARVEST TERUMO
Generic NameAPC-20 PROCEDURE PACK
Product CodeJQC
Date Received2017-08-11
Returned To Mfg2017-07-28
Catalog Number51402
Lot Number09Z9940
ID Number05020583514027
Device Expiration Date2017-09-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO BCT
Manufacturer AddressLAKEWOOD CO 80215 US 80215


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-08-11

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