WALLACE OOCYTE RECOVERY SYSTEM ONS1733

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-07-25 for WALLACE OOCYTE RECOVERY SYSTEM ONS1733 manufactured by Smiths Medical International Ltd..

Event Text Entries

[3638138] A user facility reported that 3 patients reported to hospital reporting abdominal pain following egg collection procedure with the devices listed. The patients have recovered with no reported incident related medical sequela. This report is for patient number two.
Patient Sequence No: 1, Text Type: D, B5


[11058164] Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2013-00415
MDR Report Key3267891
Report Source01,06
Date Received2013-07-25
Date of Report2013-07-23
Date of Event2013-06-26
Date Facility Aware2013-06-26
Report Date2013-07-23
Date Reported to FDA2013-07-23
Date Mfgr Received2013-06-26
Device Manufacturer Date2013-02-01
Date Added to Maude2013-08-08
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 ContactPETE HIRTE
Manufacturer Street1265 GREY FOX RD.
Manufacturer CityST. PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6516287384
Manufacturer G1SMITHS MEDICAL INTERNATIONAL LTD.
Manufacturer StreetBOUNDRY ROAD
Manufacturer CityHYTHE, KENT CT216JL
Manufacturer CountryUK
Manufacturer Postal CodeCT21 6JL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWALLACE OOCYTE RECOVERY SYSTEM
Generic NameMQE- NEEDLE, ASSISTED REPRODUCTION
Product CodeMQE
Date Received2013-07-25
Model NumberNA
Catalog NumberONS1733
Lot Number2373715
ID NumberNA
Device Expiration Date2018-01-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age4 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL INTERNATIONAL LTD.
Manufacturer AddressHYTHE, KENT UK


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2013-07-25

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