12" 4-PANEL AB BINDER 46-62 13652067

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 2002-05-02 for 12" 4-PANEL AB BINDER 46-62 13652067 manufactured by Deroyal Industries, Inc..

Event Text Entries

[272000] Patient developed skin irritation while wearing an abdominal binder. Sample from lot 865660 was returned by sales rep to qa/ra on 3/2002.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1125634-2002-00008
MDR Report Key392221
Report Source06
Date Received2002-05-02
Date of Report2002-04-26
Report Date2002-03-28
Date Mfgr Received2002-03-28
Date Added to Maude2002-05-08
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
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand Name12" 4-PANEL AB BINDER 46-62
Generic NameTLG TOP-OF-THE-LINE CHEST PRODUCTS
Product CodeFSD
Date Received2002-05-02
Model NumberNA
Catalog Number13652067
Lot Number865660
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key381250
ManufacturerDEROYAL INDUSTRIES, INC.
Manufacturer Address200 DEBUSK LANE POWELL TN 37849 US
Baseline Brand NameDEROYAL
Baseline Generic NameABDOMINAL BINDER
Baseline Model NoNA
Baseline Catalog No13652067
Baseline IDNA
Baseline Device FamilyTLG TOP OF THE LINE CHEST PRODUCTS
Baseline Shelf Life ContainedN
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2002-05-02

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