STAMMBERGER SINUS DRESSING RR 650

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-01 for STAMMBERGER SINUS DRESSING RR 650 manufactured by Arthrocare Corp..

Event Text Entries

[81561664]
Patient Sequence No: 1, Text Type: N, H10


[81561665] The patient presented with a headache and an infection two days after a procedure which involved the stammberger sinus dressing. The doctor removed the product and noted that the foam was harder and difficult to remove. No further details were provided, however no additional patient complications have been reported at this time.
Patient Sequence No: 1, Text Type: D, B5


[110229233] The product, used in treatment, was not returned for evaluation. A relationship, if any, between the product and the reported event could not be determined since the product was not returned for evaluation. Visual inspection and functional testing could not be performed because the product in question was not returned for evaluation. Thus, the customer? S complaint could not be verified, nor could a root cause be determined with confidence. It is possible the product was not sufficiently hydrated with lactated ringer solution or water, which could delay the timeline for product dissolution. It is also possible the patient did not irrigate properly after implantation. Any residual dressing that has not dissolved or left the surgical site through normal outflow passages may be easily aspirated at the discretion of the surgeon. There were no indications that would suggest that the product did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006524618-2017-00215
MDR Report Key6758536
Date Received2017-08-01
Date of Report2017-10-17
Date of Event2017-04-25
Date Mfgr Received2017-10-13
Device Manufacturer Date2016-01-31
Date Added to Maude2017-08-01
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 ContactJIM GONZALES
Manufacturer Street7000 W WILLIAM CANNON DR.
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 Received2017-08-01
Catalog NumberRR 650
Lot Number4100323
Device Expiration Date2018-01-31
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
101. Other 2017-08-01

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