FDA.reportPublic FDA data

MAUDE MDR 8518982

MDR report key
8518982
Report number
MW5085900
Event key
0
Event type
3
Date of event
2019-04-11
Date received
2019-04-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEROYAL ELASTIC BANDAGEBANDAGE, ELASTICDEROYAL INDUSTRIES, INC.FQM31-48648904201I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-150

Event Narratives#

D

Patient 1

DEROYAL ELASTIC BANDAGES WITH DEBRIS IN STERILE PACKAGE. FDA SAFETY REPORT ID# (B)(4).