MAUDE MDR 4332700

MDR report key
4332700
Report number
8022168-2014-00003
Event key
0
Event type
3
Date received
2014-12-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
, REGULATORY AFFAIRS, FEM
Address
6110 CENTER HILL AVE WINTON BUSINESS CTR CINCINNATI OH 45224 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALWAYS DISCREET LINER VERY LIGHT REGULAR LENGTHNONEPROCTER & GAMBLE, INC.NRC96613817R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-12-1501. O

Event Narratives#

D

Patient 1

ANAPHYLACTIC SHOCK [ANAPHYLACTIC SHOCK] GASPING FOR AIR [DYSPNOEA] TONGUE SWELLING, BALLOONED TO SIZE OF MOUTH [SWOLLEN TONGUE] THROAT SWELLING [PHARYNGEAL OEDEMA] LOST VOICE [APHONIA] ITCH-FEMALE GENITAL [PRURITUS GENITAL] HIVES ON CROTCH THE SIZE OF A DIME [URTICARIA] LIP SWELLING [LIP SWELLING]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, A FEMALE AGE UNSPECIFIED, TRIED ALWAYS DISCREET LINER, VERY LIGHT REGULAR LENGTH AND WAS TREATED IN THE EMERGENCY ROOM WHEN SHE WENT INTO ANAPHYLACTIC SHOCK AND WAS GASPING FOR AIR AFTER USING THE PRODUCT FOR THREE DAYS. SHE REPORTED THAT SHE BEGAN TO ITCH WHILE USING DISCREET ON THE THIRST DAY. SHE AWOKE AT 04:00 WITH HIVES THE SIZE OF A DIME ON HER CROTCH; SHE REMOVED THE LINER AND IN ABOUT AN HOUR, SHE HAD LOST HER VOICE AND HER THROAT, TONGUE, AND LIPS HAD BEGUN TO SWELL. SHE STATED THAT BY THE TIME SHE REACHED THE EMERGENCY ROOM, SHE WAS GASPING FOR AIR, HER TONGUE HAD BALLOONED TO THE SIZE OF HER MOUTH, AND SHE HAD GONE INTO ANAPHYLACTIC SHOCK . SHE WAS GIVEN SEVERAL DOSES OF EPINEPHRINE AND PREDNISONE AND MOST OF THE SWELLING HAD GONE DOWN DURING THE 4 HOURS AT THE EMERGENCY ROOM. THE CONSUMER WAS DISCHARGED TO HOME AND REPORTED THAT SHE WAS NOT ON A REGIME OF PREDNISONE AND BENADRYL FOR THE NEXT FEW DAYS. THE CASE OUTCOME WAS IMPROVED. PAST MEDICAL HISTORY INCLUDED: ALLERGY - NOT PRONE TO ALLERGIES. NO FURTHER INFO WAS PROVIDED.

N

Patient 1

A PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER. A LOT CHECK WAS REQUESTED AND PENING. CUSTOMER RELATIONS REQUESTED PRODUCT SAMPLES RETURN VIA EMAIL ON 10/29/2014.