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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCLARENT INC RELIEVA SPIN SIUSPLASTY SYSTEM; INSTRUMENT, ENT MANUAL SURGICAL

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ACCLARENT INC RELIEVA SPIN SIUSPLASTY SYSTEM; INSTRUMENT, ENT MANUAL SURGICAL Back to Search Results
Catalog Number RS0616F
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2015
Event Type  malfunction  
Event Description
When inserting the device into the patient, the wire would not bend.No patient harm.Another device obtained and procedure continued.
 
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Brand Name
RELIEVA SPIN SIUSPLASTY SYSTEM
Type of Device
INSTRUMENT, ENT MANUAL SURGICAL
Manufacturer (Section D)
ACCLARENT INC
1525-b obrian drive
menlo park CA 94025
MDR Report Key4894298
MDR Text Key6835281
Report Number4894298
Device Sequence Number1
Product Code LRC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 07/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue NumberRS0616F
Device Lot Number150220A-CM
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/06/2015
Event Location Hospital
Date Report to Manufacturer07/07/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/06/2015
Patient Sequence Number1
Patient Age37 YR
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