9CM ANTERIOR/POSTERIOR DUAL RR 900

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for 9CM ANTERIOR/POSTERIOR DUAL RR 900 manufactured by Arthrocare Corp..

Event Text Entries

[187909491] It was reported that a patient had high-velocity impact to his face by a fence post that caused extensive facial injuries, and a glasgow coma scale fluctuating between 3 and 6. He was intubated at the scene and during transit he developed brisk epistaxis therefore a 9 cm rapid rhino was used. The nasal balloon was seen to be extending through the cribriform plate and was situated within the left frontal lobe therefore it was deflated and removed manually in the emergency department. At the end, a shorter 5. 5-cm rapid rhino was used, with correct positioning confirmed radiographically. The patient had a prolonged stay in the intensive care unit and was treated prophylactically with antibiotics to prevent intracranial infection. The rapid rhino was removed after 72 hours and no further epistaxis occurred. Serial imaging demonstrated development of a traumatic encephalocele which was surgically repaired via bifrontal craniotomy. He made an uneventful recovery following this procedure and was discharged home after intensive neurorehabilitation in the hospital brain injuries rehabilitation unit. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006524618-2020-00123
MDR Report Key9875862
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-24
Date of Report2020-03-24
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactHOLLY TOPPING
Manufacturer Street7000 WEST WILLIAM CANNON DRIVE
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer Phone5123913905
Manufacturer G1ARTHROCARE CORP.
Manufacturer Street7000 W. WILLIAM CANNON
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal Code78735
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name9CM ANTERIOR/POSTERIOR DUAL
Generic NameBALLOON, EPISTAXIS
Product CodeEMX
Date Received2020-03-24
Catalog NumberRR 900
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerARTHROCARE CORP.
Manufacturer Address7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-24

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