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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ULTRA-COAT KERRISON SPURLING 40D UP 9 2MM

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INTEGRA YORK, PA INC. ULTRA-COAT KERRISON SPURLING 40D UP 9 2MM Back to Search Results
Catalog Number RB5972
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2019
Event Type  malfunction  
Manufacturer Narrative
The product was returned for evaluation. There was one ultra-coat kerrison returned used/processed showing wear. The tests/measurement used is the visual/card stock method. There was no sticking observed, and the product cut the card stock a tip-mid cut-full cut. The complaint is unconfirmed. The product tested within specifications. Device identifier: (b)(4). Linked to mfr report number: 2523190-2019-00038.
 
Event Description
1 of 2 reports. A customer reported that on (b)(6) 2019, the rb5972b, ultra-coat kerrison spurling 40d up 9 2mm was ¿sticking bad ¿during a neuro procedure. A 30-minute delay due to the product problem was reported, however there was no patient adverse consequence/or injury reported. The action that was taken after the product problem occurred was that a different size was given to the doctor from the same set. No other clinical information provided.
 
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Brand NameULTRA-COAT KERRISON SPURLING 40D UP 9 2MM
Type of DeviceULTRA-COAT
Manufacturer (Section D)
INTEGRA YORK, PA INC.
589 davies drive
589 davies drive
york PA 17402
Manufacturer (Section G)
INTEGRA YORK, PA INC.
589 davies drive
york PA 17402
Manufacturer Contact
kimberly shelly
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key8411670
MDR Text Key138795991
Report Number2523190-2019-00037
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
PMA/PMN Number
K150428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 02/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRB5972
Device Lot Number081015A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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