VENT TUBE 1016010 5PK GOODE T 1.14X12MM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2013-01-03 for VENT TUBE 1016010 5PK GOODE T 1.14X12MM manufactured by Xomed Mfg Jacksonville.

Event Text Entries

[3059546] It was reported to medtronic that in (b)(6) 2012 (exact date unknown) a vent tube was implanted in a (b)(6) male patient. After the implant procedure, the patient experienced inflammation, purulence and infection. The physician is considering explanting the device.
Patient Sequence No: 1, Text Type: D, B5


[10494305] This device is used for therapeutic purposes. The exact implant date is unknown, but was reported to be (b)(6) 2012. (b)(4). The device remains implanted and will not be returned for evaluation. The device was not returned and therefore, no evaluation could be performed.
Patient Sequence No: 1, Text Type: N, H10


[10527567] Additional information received (b)(4) 2013 confirmed the device was explanted. The explant date is unknown. The patient was treated with antibiotics and was reported to be ok. The device will not be returned as it was discarded. The patient's medical history includes middle ear effusion.
Patient Sequence No: 1, Text Type: N, H10


[101021433] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1045254-2013-00007
MDR Report Key2895319
Report Source01,05,06,FOREIGN,HEALTH PROFE
Date Received2013-01-03
Date of Report2012-12-04
Date Mfgr Received2013-02-17
Device Manufacturer Date2012-06-29
Date Added to Maude2013-01-03
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 ContactJONATHAN SCHLECH
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal32216
Manufacturer Phone9043328355
Manufacturer G1MEDTRONIC XOMED, INC
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal Code32216
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENT TUBE 1016010 5PK GOODE T 1.14X12MM
Generic NameTUBE, TYMPANOSTOMY
Product CodeETD
Date Received2013-01-03
Model Number1016010
Catalog Number1016010
Lot Number0206005229
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerXOMED MFG JACKSONVILLE
Manufacturer Address6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-01-03

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