DEROYAL C24250060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-02-04 for DEROYAL C24250060 manufactured by Deroyal Industries, Inc..

Event Text Entries

[177930] The same health care professional applied the splinting system using the same methods as described in the narrative of report number 1624487-2000-00001. The failure to follow the instructions again could have been the cause of this incident after the splint was applied. After the splint was removed, a slight discoloration of the skin was evident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1624487-2000-00002
MDR Report Key261617
Report Source06
Date Received2000-02-04
Date of Report2000-02-02
Date of Event2000-01-06
Report Date2000-02-02
Date Reported to FDA2000-02-02
Date Mfgr Received2000-01-06
Date Added to Maude2000-02-11
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 FDA3
Event Location3
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone4239387828
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameDEROYAL
Generic NameUNIVERSAL SPLINTING SYSTEM
Product CodeLGF
Date Received2000-02-04
Returned To Mfg2000-01-12
Model NumberNA
Catalog NumberC24250060
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeUNKNOWN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key253372
ManufacturerDEROYAL INDUSTRIES, INC.
Manufacturer Address200 DEBUSK LANE POWELL TN 37849 US
Baseline Brand NameDEROYAL
Baseline Generic NameSPLINTING SYSTEM
Baseline Model NoNA
Baseline Catalog NoC24250060
Baseline IDNA
Baseline Device FamilyCASTING PRODUCTS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2000-02-04

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