STAMMBERGER SINUS DRESSING EDRR 650

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-02 for STAMMBERGER SINUS DRESSING EDRR 650 manufactured by Arthrocare Corp..

Event Text Entries

[98984506] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[98984507] It was reported that dissolvable foam inserted intra-nasally did not dissolve and patient required further surgery to clean sinuses. This condition did not cause any damage to the patient, device did not require to be replaced or removed. As per reporter, there is no further information regarding lot number or patient information.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006524618-2018-00061
MDR Report Key7237643
Date Received2018-02-02
Date of Report2018-03-12
Date Mfgr Received2018-03-11
Date Added to Maude2018-02-02
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 ContactJIM GONZALES
Manufacturer Street7000 W. WILLIAM CANNON DRIVE
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
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 Report0

Device Details

Brand NameSTAMMBERGER SINUS DRESSING
Generic NameSPLINT, INTRANASAL SEPTAL
Product CodeLYA
Date Received2018-02-02
Catalog NumberEDRR 650
Lot NumberUNKNOWN
Device Expiration Date2018-01-05
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARTHROCARE CORP.
Manufacturer Address7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-02

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