FDA.reportPublic FDA data

MAUDE MDR 395362

MDR report key
395362
Report number
2320947-2002-00001
Event key
0
Event type
3
Date of event
2002-04-19
Date received
2002-05-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
200 DEBUSK LANE POWELL TN 37849 US
Phone
865-865-8659
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
14442-00 COOL BLUE SLING/SWATHE UNIVTLH TOP-OF-THE-LINE SHOULDER PRODSDEROYAL INDUSTRIES, INC.ILINA4442-00UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-05-1501. O

Event Narratives#

D

Patient 1

PATIENT DEVELOPED RED ITCHY RASH ON THE RIGHT FOREARM WHERE THE FOAM LINING OF A SLING AND SWATHE IS TOUCHING THE SKIN. THE RASH WAS NOTICED BY THE NURSE. THIS PT IS TRANSFERRED TODAY FROM THE HOSPITAL TO THE REHAB HOSPITAL THE DEVICE WAS PUT ON THE PATIENT AT THE HOSPITAL. THE PRODUCT IS DESCRIBED AS DEEP BLUE PERFORATED MATERIAL WITH CREAM COLORED FOAM LINING, AND HAS TENTATIVELY BEEN IDENTIFIED AS 4442-00. MINX CHECK OF LABELING FOR THIS PRODUCT NUMBER INDICATED THAT IT CONTAINS NATURAL RUBBER LATEX. THIS INFORMATION WAS GIVEN TO THE NURSE.