DEROYAL D6201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-03-05 for DEROYAL D6201 manufactured by Swann Morton, Ltd..

Event Text Entries

[4298770] The scalpel is cutting jagged, basically tearing a vein. The doctors have changed to another brand.
Patient Sequence No: 1, Text Type: D, B5


[11551735] Deroyal: the investigation into the root cause is in process. The reported device has not been returned at this time. There have been no similar complaints filed for this product line prior to this customer filing three reports on this issue.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1060680-2014-00002
MDR Report Key3674393
Report Source08
Date Received2014-03-05
Date of Report2014-02-11
Date of Event2014-02-10
Date Facility Aware2014-02-10
Report Date2014-02-11
Date Reported to Mfgr2014-02-11
Date Mfgr Received2014-02-11
Date Added to Maude2014-03-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactCOURTNEY RINEHART
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8653622122
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEROYAL
Generic NameSCALPEL, ONE PIECE
Product CodeGDX
Date Received2014-03-05
Catalog NumberD6201
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSWANN MORTON, LTD.
Manufacturer AddressSHEFFIELD UK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-03-05

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