COMPLIANCE ENDOKIT CEK-880-20 2088-06

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-30 for COMPLIANCE ENDOKIT CEK-880-20 2088-06 manufactured by Boston Scientific Corporation.

Event Text Entries

[143618181] The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown. (b)(4). According to the complainant, the suspect device has been disposed and is not available for return; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[143618182] It was reported to boston scientific corporation that a compliance endokit was used on (b)(6) 2019. According to the complainant, during preparation, when the technician opened the kit, there were overwhelming fumes which caused the technician to have an allergic reaction. The technician was taken to the emergency room. It is unknown as to what treatment was given to the technician in the emergency room however they were reported to be fine and stable following treatment. There was no patient involvement with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-02296
MDR Report Key8566835
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-04-30
Date of Report2019-04-30
Date of Event2019-04-05
Date Mfgr Received2019-04-05
Date Added to Maude2019-04-30
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 ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1ENDOCHOICE
Manufacturer Street11810 WILLS ROAD ,
Manufacturer CityALPHARETTA GA 30009
Manufacturer CountryUS
Manufacturer Postal Code30009
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPLIANCE ENDOKIT
Generic NameCONVENIENCE KIT
Product CodeMNL
Date Received2019-04-30
Model NumberCEK-880-20
Catalog Number2088-06
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-04-30

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