ENVISION FLEX TARGET RETRIEVAL SOLUTION, LOW PH (50X) (LINK) K8005

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 2017-07-14 for ENVISION FLEX TARGET RETRIEVAL SOLUTION, LOW PH (50X) (LINK) K8005 manufactured by Dako North America, Inc..

Event Text Entries

[80126285] The customer reported an incident to dako on the (b)(6) 2017. Three female laboratory employees (initials (b)(6) and unknown) were reported to have allergic reactions to the product envision flex target retrieval solution, low ph (50x) (link), code no k8005. The product k8005 is a vial in the sk00621-2 kit, lot 10121768, exp. Date 2017-10-31. It was reported that the reactions varied in intensity and consisted of erythema, burning/stinging/itching feeling, red spots and/or blisters on cheeks and neck. (b)(6) exhibited symptoms on (b)(6) 2017; (b)(6) was the only person to exhibit the more major symptoms. According to the information received by dako, (b)(6) experienced symptoms on (b)(6) 2017 and no other times could be recalled. Deparaffinization, rehydration and target retrieval of the tissue slides was performed in the pt link instrument using k8005 on the dates of (b)(6) 2017. None of the three persons ((b)(6) and unknown) who had the reactions were trained to use product k8005 or the pt link instrument. (b)(6) worked partly in the same room as the pt link was situated the (b)(6) 2017. Apart from this the three affected persons were not in the room on the dates set forth above. Other personnel at the site were trained on the use of the product and instrument by an application specialist on the dates of (b)(6) 2017. The five trained employees have not reported any reactions. On (b)(6) 2017, (b)(6) worked in another laboratory down the corridor. The customer prepared the k8005 solution in the pt link as trained and the run was started. When half of the heating incubation time at 97? C had passed, (b)(6) came to the lab (the door to the corridor closed) and told the customer that she felt the allergic reaction again and would go home. On (b)(6) 2017 a closed vial of k8005 in a sealed bag was placed next to (b)(6) computer. On (b)(6) 2017, (b)(6) was working on the same floor where the pt link instrument had been moved within the laboratory; (b)(6) was working in the room next to the laboratory where the k8005 was being used, both experienced symptoms. The symptoms resolved when (b)(6) left the building. (b)(6) was treated with cortisone (betapred - betametasonnatriumfosfat 0,5 mg tablets), administered start and end date (b)(6) 2017. Mg treated herself with an antihistamine, deslortadine teva tablets (5mg), on (b)(6) 2017, as she experiences hives now and then. Root cause is being investigated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2022180-2017-00002
MDR Report Key6715866
Report SourceHEALTH PROFESSIONAL
Date Received2017-07-14
Date of Report2017-09-29
Date of Event2017-05-29
Date Mfgr Received2017-06-14
Date Added to Maude2017-07-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MANI SIRAVANTA
Manufacturer Street6392 VIA REAL
Manufacturer CityCARPINTERIA CA 93013
Manufacturer CountryUS
Manufacturer Postal93013
Manufacturer Phone8055665462
Manufacturer G1DAKO NORTH AMERICA, INC.
Manufacturer Street6392 VIA REAL
Manufacturer CityCARPINTERIA CA 93013
Manufacturer CountryUS
Manufacturer Postal Code93013
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENVISION FLEX TARGET RETRIEVAL SOLUTION, LOW PH (50X) (LINK)
Generic NameIMMUNOHISTOCHEMISTRY, ANTIGEN RETRIEVAL REAGENT, IVD
Product CodePPM
Date Received2017-07-14
Catalog NumberK8005
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDAKO NORTH AMERICA, INC.
Manufacturer Address6392 VIA REAL CARPINTERIA CA 93013 US 93013


Patients

Patient NumberTreatmentOutcomeDate
108. ; 8. 2017-07-14

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