FDA.reportPublic FDA data

MAUDE MDR 7116558

MDR report key
7116558
Report number
MW5073957
Event key
0
Event type
3
Date of event
2017-12-08
Date received
2017-12-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1MIAMI J COLLARORTHOSIS, CERVICALOSSUR AMERICASIQKMJP-0871MX170925I *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-130

Event Narratives#

D

Patient 1

PROVIDER ORDERED SOFT COLLAR FOR PATIENT DUE TO POTENTIAL NECK TRAUMA IN CASE OF PATIENT WITH ALTERED MENTAL STATUS WITH UNKNOWN ETIOLOGY. I RETRIEVED A COLLAR THAT WAS STILL IN ITS ORIGINAL PACKAGING, WHEN PACKAGING WAS OPENED, IT DID NOT CONTAIN THE FRONT HALF OF THE COLLAR. REMOVED THE COLLAR FROM CIRCULATION AND RETRIEVED ANOTHER (WHICH WAS THE LAST IN STOCK). CREATED SITUATION OF AN UNSAFE CONDITION THAT COULD HAVE SIGNIFICANTLY DELAYED APPLICATION OF A NECESSARY MEDICAL DEVICE.