21903 ARM SLING W/SWATHE - LARGE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2002-05-15 for 21903 ARM SLING W/SWATHE - LARGE manufactured by Deroyal Industries, Inc..

Event Text Entries

[15256803] While wearing the armsling, the patient developed a rash all around the neck area. Patient reported having a history of a latex / adhesive allergy. Patient is currently wearing a scarf around neck to keep the strap from touching their neck. Patient also mentioned that arm doesn't stay put very well in the arm pocket area. Company staff person ordered a 9014-00 and a tx9905-03 to be sent next day air as replacements. Ups will pick up the original arm sling and return it to the company.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1037420-2002-00005
MDR Report Key402191
Report Source04
Date Received2002-05-15
Date of Report2002-05-07
Date of Event2002-04-10
Date Mfgr Received2002-04-11
Date Added to Maude2002-07-01
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 Location0
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 Name21903 ARM SLING W/SWATHE - LARGE
Generic NameBDH BID LINE SHOULDER PRODUCTS
Product CodeILI
Date Received2002-05-15
Model NumberNA
Catalog Number21903
Lot NumberUNK
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key391213
ManufacturerDEROYAL INDUSTRIES, INC.
Manufacturer Address200 DEBUSK LANE POWELL TN 37849 US
Baseline Brand Name21903 ARM SLING W/SWATHE-L
Baseline Generic NameARM SLING
Baseline Model NoNA
Baseline Catalog No21903
Baseline IDNA
Baseline Device FamilySHOULDER PRODUCTS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2002-05-15

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