FDA.reportPublic FDA data

MAUDE MDR 3281685

MDR report key
3281685
Report number
1022110-2013-00002
Event key
0
Event type
3
Date of event
2013-07-18
Date received
2013-08-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
1900 SECTION RD. CINCINNATI OH 45237 US
Phone
513-513-5134
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1E-Z LUBRICATING JELLY.CHESTER PACKAGINGKMJ000304UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-08-0301. O; 2. R

Event Narratives#

D

Patient 1

PATIENT DEVELOPED AN IMMEDIATE REACTION AFTER AN ANOSCOPE TEST WHERE A SCOPE IS INSERTED IN THE ANUS. THE PATIENT'S REACTION WAS ANAPHYLAXIS. REACTION SYMPTOMS BEGAN ABOUT TEN MINUTES AFTER THE PROCEDURE AND INVOLVED FACIAL SWELLING AND REDNESS, LIP SWELLING. THE PATIENT USED A SELF-PRESCRIBED ANTIHISTAMINE, XYZAL THAT HE CARRIED WITH HIM. HE ALSO CARRIES AN EPI PEN BUT DID NOT USE IT. HIS SYMPTOMS RESOLVED AFTER TAKING THE MEDICATION. THE PATIENT HAS A KNOWN ALLERGY TO POLYETHYLENE GLYCOL WHICH IS AN INGREDIENT IN THE E-Z LUBRICATING JELLY. A PRODUCT INGREDIENT STATEMENT AND MSDS WAS REQUESTED.

N

Patient 1

THE PATIENT HAD A KNOWN ALLERGY TO POLYETHYLENE GLYCOL WHICH IS AN INGREDIENT IN E-Z LUBRICATING JELLY WHICH WAS THE ROOT CAUSE FOR THE REPORTED REACTION. THE PATIENT USED A SELF-PRESCRIBED ANTIHISTAMINE, ZYZAL, AND HIS SYMPTOMS RESOLVED AFTER TAKING THE MEDICATION. HE WAS DISCHARGED WITHOUT FURTHER COMPLICATIONS. THE NURSE REQUESTED AND RECEIVED A COPY OF THE LUBRICATING JELLY INGREDIENT STATEMENT AND AN MSDS.