ARTHREX ANGEL PRP KIT (US TRAY) ABS-10061T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-20 for ARTHREX ANGEL PRP KIT (US TRAY) ABS-10061T manufactured by Arthrex, Inc..

Event Text Entries

[187077381] The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The device was reported to have been discarded. The root cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10


[187077382] It was reported that during a prp injection, the abs-10061t, malfunctioned. The cassette portion of the kit broke when it started spinning and the blood drained into the machine. The facility ended up losing all the blood that was drawn but the surgeon wanted to go ahead and try again with a second kit. The second kit was successful. Additional information requested on 12/30/2019. Additional information received 12/30/2019: it was reported that during an arthroscopic meniscal repair with prp injection, the abs-10061t, malfunctioned. The cassette portion of the kit broke when it started spinning and the blood drained into the machine. The facility ended up losing all the blood that was drawn but the surgeon wanted to go ahead and try again with a second kit which was successful. It was found that blood splattered onto the surrounding walls and around the cart that the angel machine was sitting on. The rep cleaned the walls, cart, and surrounding areas with towels and cleaning solution. The rep also cleaned the blood that was in and on the angel machine with towels and cleaning solution.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220246-2020-01582
MDR Report Key9607408
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-01-20
Date of Report2020-01-20
Date of Event2019-12-27
Date Mfgr Received2019-12-30
Device Manufacturer Date2018-06-01
Date Added to Maude2020-01-20
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 ContactVIK BAJNATH
Manufacturer Phone8009337001
Manufacturer G1ARTHREX, INC.
Manufacturer Street1370 CREEKSIDE BOULEVARD
Manufacturer CityNAPLES FL 341081945
Manufacturer CountryUS
Manufacturer Postal Code341081945
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARTHREX ANGEL PRP KIT (US TRAY)
Generic NamePLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
Product CodeORG
Date Received2020-01-20
Model NumberARTHREX ANGEL PRP KIT (US TRAY)
Catalog NumberABS-10061T
Lot Number918495126
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerARTHREX, INC.
Manufacturer Address1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-20

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