FDA.reportPublic FDA data

MAUDE MDR 8277961

MDR report key
8277961
Report number
MW5083391
Event key
0
Event type
3
Date of event
2019-01-22
Date received
2019-01-24
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
1PILLINGBOUGIE, ESOPHAGEAL, ENTTELEFLEX MEDICALKCD* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-2401. R

Event Narratives#

D

Patient 1

MFR IDENTIFIED ISSUES WITH THE OUTER PACKAGING OF THE PRODUCTS BEING IMPROPERLY LABELED. THE PRODUCT ITSELF IS PROPERLY LABELED. BECAUSE OF THIS, MANUFACTURER RECOMMENDS REMOVING PRODUCT CONTAINERS OUT OF SERVICE. HOWEVER, OUR FACILITY ALWAYS IMMEDIATELY REMOVES ITEMS FROM THE CONTAINER AND VERIFIES SIZE ON THE DEVICE ITSELF. AND SINCE THE DEVICE ITSELF IS NOT AN ISSUE, AND PACKAGING IS IMMEDIATELY DISCARDED, NO FURTHER ACTION IS NEEDED AT THIS TIME.