ULTRA-COAT KERRISON SPURLING 40D UP 9 2MM RB5972

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for ULTRA-COAT KERRISON SPURLING 40D UP 9 2MM RB5972 manufactured by Integra York, Pa Inc..

Event Text Entries

[138795991] 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.
Patient Sequence No: 1, Text Type: N, H10


[138795992] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523190-2019-00037
MDR Report Key8411670
Date Received2019-03-12
Date of Report2019-02-18
Date of Event2019-02-18
Date Mfgr Received2019-02-18
Date Added to Maude2019-03-12
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 ContactUSER KIMBERLY SHELLY
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA YORK, PA INC.
Manufacturer Street589 DAVIES DRIVE
Manufacturer CityYORK PA 17402
Manufacturer CountryUS
Manufacturer Postal Code17402
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameULTRA-COAT KERRISON SPURLING 40D UP 9 2MM
Generic NameULTRA-COAT
Product CodeHAE
Date Received2019-03-12
Returned To Mfg2019-02-25
Catalog NumberRB5972
Lot Number081015A
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer Address589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-12

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