DU PLASTER BDG XFST UNK.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-09-28 for DU PLASTER BDG XFST UNK. manufactured by Deroyal.

Event Text Entries

[170069] A carapace product, (unable to confirm product number), after being wet down with extremely hot water was placed on pts leg. Pt complained of great pain far in excess of the pain from pt's broken leg, but was transferred to another facility approximately an hour away. When cast was removed at this facility, pt had 2nd and 3rd degree burns.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1624487-2000-00003
MDR Report Key298300
Report Source07
Date Received2000-09-28
Date of Report2000-09-27
Date of Event2000-08-30
Report Date2000-09-27
Date Reported to FDA2000-09-27
Date Mfgr Received2000-09-13
Date Added to Maude2000-10-03
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 Phone8659387828
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 NameDU PLASTER BDG XFST
Generic NamePLASTER BANDAGE
Product CodeLGF
Date Received2000-09-28
Model NumberNA
Catalog NumberUNK.
Lot NumberUNK.
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key288747
ManufacturerDEROYAL
Manufacturer Address200 DEBUSK LANE POWELL TN 37849 US
Baseline Brand NameDU PLASTER BDG XFST
Baseline Generic NamePLASTER BANDAGE
Baseline Model NoNA
Baseline Catalog NoUNK.
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2000-09-28

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