FLEXIMA? M001271800 27-180

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 2018-07-27 for FLEXIMA? M001271800 27-180 manufactured by Boston Scientific - Costa Rica (coyol).

Event Text Entries

[115367019] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[115367020] Same case as mdr id: 2134265-2018-07013. It was reported that foreign matter was observed on the device. Two 10. 3 flexima drainage catheters were selected for use. During the procedure, the physician put two flexima catheters in the patient; however, it was noted that both catheters leaked around the hub. It was further noted that there was like a small piece of a thread coming out of the catheter hub where the physician thought it was leaking. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2018-07014
MDR Report Key7726671
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-07-27
Date of Report2018-07-05
Date of Event2018-07-05
Date Mfgr Received2018-08-20
Device Manufacturer Date2018-05-02
Date Added to Maude2018-07-27
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 ContactEMP. SONALI ARANGIL
Manufacturer StreetONE SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634941700
Manufacturer G1BOSTON SCIENTIFIC - COSTA RICA (COYOL)
Manufacturer Street2546 FIRST STREET PROPARK FREE ZONE
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXIMA?
Generic NameTUBE, DRAINAGE, SUPRAPUBIC
Product CodeFFA
Date Received2018-07-27
Returned To Mfg2018-07-13
Model NumberM001271800
Catalog Number27-180
Lot Number22056318
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - COSTA RICA (COYOL)
Manufacturer Address2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.