OVUM ASPIRATION NEEDLE SINGLE LUMEN K-OSN-1735-B-90-US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-19 for OVUM ASPIRATION NEEDLE SINGLE LUMEN K-OSN-1735-B-90-US manufactured by William A. Cook Australia, Pty Ltd.

Event Text Entries

[106004732] Pma/510(k) granted on the 12 january 2018: k171625. Event was reported to happen between (b)(6) 2017 and the (b)(6) 2018.
Patient Sequence No: 1, Text Type: N, H10


[106004733] The patient developed an infection (bilateral tubal ovarian abscess) after having an ovum aspiration performed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680654-2018-00012
MDR Report Key7445458
Date Received2018-04-19
Date of Report2018-06-06
Date of Event2018-03-10
Date Mfgr Received2018-03-26
Date Added to Maude2018-04-19
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 ContactMR NICOLAS BIDAUD
Manufacturer Street95 BRANDL STREET EIGHT MILE PLAINS
Manufacturer CityBRISBANE QLD 4113
Manufacturer CountryAS
Manufacturer PostalQLD 4113
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameOVUM ASPIRATION NEEDLE SINGLE LUMEN
Generic NameMQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES
Product CodeMQE
Date Received2018-04-19
Catalog NumberK-OSN-1735-B-90-US
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerWILLIAM A. COOK AUSTRALIA, PTY LTD
Manufacturer Address95 BRANDL STREET EIGHT MILE PLAINS BRISBANE QLD 4113 AS QLD 4113


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-19

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