FDA.reportPublic FDA data

MAUDE MDR 2617558

MDR report key
2617558
Report number
MW5025774
Event key
0
Event type
3
Date received
2012-06-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VERSA PRO EXAM GLOVESEXAM GLOVES/100 PER BOX*LYY**34-GG-888

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-06-140

Event Narratives#

D

Patient 1

REPORTER CALLED ON BEHALF OF HER SON. SHE STATED HER SON IS A RECENT TRACHEOSTOMY PT. SHE SAYS SHE USES EXAM GLOVES TO CLEAN THE SITE. SHE STATED SHE OPENED A NEW BOX AND AFTER USING A FEW GLOVES?SHE PULLED ONE OUT THAT APPEARED CONTAMINATED. SHE REPORTED THAT A FINGERTIP OF A GLOVE HAD A YELLOW/BROWNISH FOREIGN SUBSTANCE ON IT, POSSIBLY CAME IN CONTACT WITH A LIQUID. REPORTER STATED HER SON HAS BEEN SUFFERING FROM INFECTIONS, BUT SHE?S NOT SURE IF THE INFECTIONS ARE RELATED TO THE GLOVES. SHE SAID SHE STOPPED USING THE BOX OF GLOVES AND HER SON WAS PUT ON ANTIBIOTICS AND IS DOING MUCH BETTER NOW. SHE STATED SHE IS USING ANOTHER BRAND OF GLOVES NOW AND HAS HAD NO PROBLEMS WITH INFECTIONS.