MAUDE MDR 1927761

MDR report key
1927761
Report number
2411236-2010-00008
Event key
0
Event type
3
Date of event
2010-11-08
Date received
2010-12-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ILLUSION GLOVE STRAWBERRYLATEX EXAMINATION GLOVEOON CORP RESOURCESLYY112-4992666070* R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-12-0701. O
22010-12-070
32010-12-070
42010-12-070

Event Narratives#

D

Patient 1

THE OFFICE ALLEGES FOUR STAFF MEMBERS EXPERIENCED EYE IRRITATION AND A RASH ON THEIR HANDS AS FOLLOWS: PATIENT EXPERIENCED EYE IRRITATION. NONE OF THE STAFF MEMBERS REQUIRED ANY MEDICAL ATTENTION OTHER THAN THE ONE STAFF MEMBER WHO HAD HER EYES IRRIGATED WITH THE SALINE SOLUTION.

D

Patient 3

THE OFFICE ALLEGES FOUR STAFF MEMBERS EXPERIENCED EYE IRRITATION AND A RASH ON THEIR HANDS AS FOLLOWS: PATIENT EXPERIENCED HAND AND EYE IRRITATION. NONE OF THE STAFF MEMBERS REQUIRED ANY MEDICAL ATTENTION OTHER THAN THE ONE STAFF MEMBER WHO HAD HER EYES IRRIGATED WITH THE SALINE SOLUTION.

D

Patient 4

THE OFFICE ALLEGES FOUR STAFF MEMBERS EXPERIENCED EYE IRRITATION AND A RASH ON THEIR HANDS AS FOLLOWS: PATIENT EXPERIENCED A RASH ON HER HAND AND EYE IRRITATION WHICH REQUIRED HER EYES TO BE IRRIGATED WITH SALINE AND LUBRICATING DROPS. SHE ALSO HAD SWOLLEN EYES. NONE OF THE STAFF MEMBERS REQUIRED ANY MEDICAL ATTENTION OTHER THAN THE ONE STAFF MEMBER WHO HAD HER EYES IRRIGATED WITH THE SALINE SOLUTION.

D

Patient 2

THE OFFICE ALLEGES FOUR STAFF MEMBERS EXPERIENCED EYE IRRITATION AND A RASH ON THEIR HANDS AS FOLLOWS: PATIENT EXPERIENCED HAND AND EYE IRRITATION. NONE OF THE STAFF MEMBERS REQUIRED ANY MEDICAL ATTENTION OTHER THAN THE ONE STAFF MEMBER WHO HAD HER EYES IRRIGATED WITH THE SALINE SOLUTION.