FDA.reportPublic FDA data

MAUDE MDR 11390

MDR report key
11390
Report number
MW4000171
Event key
0
Event type
3
Date of event
1993-06-15
Date received
1994-02-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
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
1EXTRA HEAVY GREEN RUBBER DAMHYGENIC CORP.EIEN*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-02-030

Event Narratives#

D

Patient 1

ALLERGIC REACTION/CONTACT DERMATITIS.