FDA.reportPublic FDA data

MAUDE MDR 402191

MDR report key
402191
Report number
1037420-2002-00005
Event key
0
Event type
3
Date of event
2002-04-10
Date received
2002-05-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

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
121903 ARM SLING W/SWATHE - LARGEBDH BID LINE SHOULDER PRODUCTSDEROYAL INDUSTRIES, INC.ILINA21903UNKNRY

Patients#

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

Event Narratives#

D

Patient 1

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.