FDA.reportPublic FDA data

MAUDE MDR 7805571

MDR report key
7805571
Report number
MW5079298
Event key
0
Event type
3
Date of event
2018-08-08
Date received
2018-08-21
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
1LUBRICATING JELLYLUBRICANT, PATIENTHENRY SCHEIN, INC.KMJI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-2101. O

Event Narratives#

D

Patient 1

REPORTER STATES THAT ON (B)(6) 2018 SHE HAD A PAP SMEAR AT HER PHYSICIAN'S OFFICE AND HAD A VERY SEVERE REACTION TO THE LUBRICATION USED. PATIENT HAS A HX OF VULVODYNIA AND BELIEVES THIS EVENT HAS CAUSED A FLAREUP. SHE GOES ON TO SAY THAT THESE FLAREUPS FEEL LIKE HER "WHOLE BODY IS ON FIRE" AND COULD LAST YEARS. SHE HAD TO QUIT HER JOB AND IS UNSURE WHAT TO DO.