FDA.reportPublic FDA data

MAUDE MDR 9828921

MDR report key
9828921
Report number
MW5093722
Event key
0
Event type
3
Date of event
2020-03-11
Date received
2020-03-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GEL-ONE 30MG/3MLACID, HYALURONIC, INTRAARTICULARSEIKAGAKU CORPORATION, TAKAHAGI PLANTMOZ N
10130MG/3ML---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-120

Event Narratives#

D

Patient 1

THE DR'S OFFICE IS PRESCRIBING GEL-ONE TO BE ADMINISTERED INTO THE LEFT SHOULDER OF LABEL.