FDA.reportPublic FDA data

MAUDE MDR 1750835

MDR report key
1750835
Report number
2211100-2010-00010
Event key
0
Event type
3
Date received
2010-04-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
999
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
100 TOURNAMENT DRIVE HORSHAM PA 19044 US
Phone
215-215-2153
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE)HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIESJOHNSON & JOHNSON MEDICAL BRAZIL (JJMB)HDWUNKUNKUNK* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-04-2701. O

Event Narratives#

D

Patient 1

THIS SPONTANEOUS REPORT RECEIVED FROM A PATIENT CONCERNS AN (B)(6), FEMALE, FROM THE UNITED STATES: (B)(4). THE PATIENT'S MEDICAL HISTORY AND CONCURRENT CONDITIONS INCLUDED: UTERINE PROLAPSE. THE PATIENT'S HEIGHT AND WEIGHT WERE NOT REPORTED. THE PATIENT HAD A PREVIOUS HISTORY OF USING THE ORTHO ALL-FLEX ARCING SPRING DIAPHRAGM MADE OF LATEX FOR OVER TWENTY (20) YEARS WITHOUT ANY INCIDENT OR ADVERSE EVENT. THE PATIENT WAS TREATED WITH AN ORTHO ALL-FLEX ARCING SPRING DIAPHRAGM MADE OF SILICONE FOR UTERINE PROLAPSE. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT REPORTED THAT TWO (2) HOURS AFTER INSERTING THE DIAPHRAGM, SHE DEVELOPED A SEVERE INFECTION (VAGINAL AND URINARY TRACT). THE PATIENT STATED THAT SHE "WOULD NOT BE ABLE TO USE ANY KIND OF VAGINALLY INSERTABLE DEVICE AGAIN BECAUSE OF THE DAMAGE SHE NOW HAS TO LIVE WITH". THE PATIENT'S OUTCOME WAS UNKNOWN FOR THE VAGINAL INFECTION AND URINARY TRACT INFECTION. THIS REPORT WAS SERIOUS (MEDICALLY SIGNIFICANT).