MEDTRONIC VENT TUBE XOM UNK VENT TUBE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2017-11-21 for MEDTRONIC VENT TUBE XOM UNK VENT TUBE manufactured by Medtronic Xomed Inc..

Event Text Entries

[92651085] Product evaluation: analysis results are not available; device not returned for evaluation. Case 1 of 2 will be submitted on a separate mdr. Medtronic internal reference (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[92651086] This report addresses adult 2 of 2 identified in the study. During a study of 56 patients to assess effectiveness of grommet insertion compared with non surgical treatment steroids in otitis media effusion (ome) cases, 2 adults were identified with permanent perforation of the tympanic membrane. The study is captured in the following literature article: chavan ss, nagpure ps. Comparative assessment of grommets with topical intranasal steroid in cases of otitis media with effusion. Indian j otology 2017; 23:146-50. Overall, "there was more improvement, less complications, and less failure rate in patient treated with myringotomy with grommet insertion than in patients which received intranasal steroids. " subjects of various age groups attending out patient department of ent, kasturba hospital, mgims sevagram, hospital, wardha from june 2013 to august 2015 who meet the inclusion criteria and gave their written consent in local language were included in the study. Doi (digital object identifier): 10. 4103/indianjotol. Indianjotol_46_17.
Patient Sequence No: 1, Text Type: D, B5


[102356410] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[102356411] Correction (case 2 of 2): it was confirmed that the perforation was not due to a defect or malfunction; rather, it was caused by "the aggressiveness" of the disease itself. None of the outcomes reported in the research were caused or contributed to by the vent tube. No additional procedures or medical interventions were required to treat the outcomes; the patients healed by themselves.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1045254-2017-00422
MDR Report Key7049513
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2017-11-21
Date of Report2018-02-23
Date of Event2017-09-01
Date Mfgr Received2018-02-23
Date Added to Maude2017-11-21
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 ContactANGIE DEMO
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal32216
Manufacturer Phone9043328355
Manufacturer G1MEDTRONIC XOMED INC.
Manufacturer Street6743 SOUTHPOINT DR N
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal Code32216
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDTRONIC VENT TUBE
Generic NameTUBE, TYMPANOSTOMY
Product CodeETD
Date Received2017-11-21
Model NumberXOM UNK VENT TUBE
Catalog NumberXOM UNK VENT TUBE
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC XOMED INC.
Manufacturer Address6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-11-21

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