MAUDE MDR 5187623

MDR report key
5187623
Report number
MW5057542
Event key
0
Event type
3
Date of event
2015-10-22
Date received
2015-10-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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
1LATEX GLOVESLATEX GLOVESEUDERMICLYY* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-10-2301. L

Event Narratives#

D

Patient 1

I VISITED (B)(6) 2015 WITH MY DAUGHTER. SHE WAS IN PAIN FROM A PREVIOUS CAR WRECK/MULTIPLE OVARIAN CYSTS. THE STAFF WAS NOTIFIED THAT I AM TYPE I LATEX ALLERGIC AND THAT SHE HAD CONTACT LATEX ALLERGY. WE WERE STILL PUT IN A ROOM CONTAINING LATEX GLOVES. WITHIN MINUTES I WENT INTO ANAPHYLAXIS AND ADMINISTERED EPINEPHRINE. I USED MY RESCUE INHALER AND TOOK 50MG OF BENADRYL IN FRONT OF THE ATTENDING PHYSICIAN. NO CHECK WAS PERFORMED. AFTER MY EPI, THE REACTION QUICKLY SUBSIDED FOR A FEW MINUTES. MY DAUGHTER WAS TAKEN TO RADIOLOGY, AND I WAS LEFT ALONE IN THE ROOM. THE REACTION STARTED AGAIN, AND ANOTHER EPIPEN AND 50MGS OF BENADRYL WERE NEEDED. THE EPI PENS WERE LEFT OUT FOR THE DOCTOR IN CASE I BECAME UNCONSCIOUS. THE DOCTOR NEVER ASKED HOW I WAS. HE LOOKED AT THE EPI PENS BUT MADE NO COMMENT. I EMAILED THE HOSPITAL ADMINISTRATION AND CEO THE FOLLOWING DAY AND WAS TOLD LATEX HAD BEEN REMOVED FROM ALL THE ROOMS. LAST NIGHT, (B)(6) 2015, I WENT BACK TO (B)(6) WITH ANAPHYLAXIS FROM LATEX EXPOSURE (AIRBORNE). I WAS IN ROOM 4, AND REQUIRED 2 EPI PENS, BENADRYL, STEROIDS, AND OXYGEN. THE LONGER I STAYED IN THE ROOM THE WORSE I FELT. MY HUSBAND FOUND A BIN OF LATEX GLOVES ON THE COUNTER. THESE ARE MY MOST RECENT EXPERIENCES AT THIS HOSPITAL, BUT DEFINITELY NOT ALL. EACH TIME I HAVE PRESENTED WITH ANAPHYLAXIS FROM LATEX EXPOSURE I HAVE BEEN PLACED IN ROOMS WITH LATEX. AT THIS PINT I FEEL MY RIGHTS UNDER (B)(4) HAVE BEEN VIOLATED, AND THAT I AM A VICTIM OF MEDICAL NEGLIGENCE.