ALL-FLEX ARCHING SPRING DIAPHRAGM UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-03-22 for ALL-FLEX ARCHING SPRING DIAPHRAGM UNK manufactured by R.w. Johnson Pharm. Res. Inst. Usa/div. Of Ortho Pharmaceutical Corp..

Event Text Entries

[17429577] Consumer reports that in 1995 or 1996 while using an all-flex arching spring diaphragm, pt became pregnant then miscarried. States prior to this event, pt had been using this same all-flex in between having four children. Reportedly, pt asked their physician if they should be re-fitted each time they had a child, but was told they did not need a new size. Subsequently md has re-fitted pt and found that pt needed a larger diaphragm. No further info available at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2211100-2001-00010
MDR Report Key322210
Report Source04
Date Received2001-03-22
Date of Report2001-03-06
Date of Event1996-01-01
Date Mfgr Received2001-02-20
Date Added to Maude2001-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer Street920 U.S. RTE 202 P.O. BOX 300
Manufacturer CityRARITAN NJ 08869
Manufacturer CountryUS
Manufacturer Postal08869
Manufacturer Phone9087044504
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALL-FLEX ARCHING SPRING DIAPHRAGM
Generic NameDIAPHRAGM
Product CodeHDW
Date Received2001-03-22
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key311701
ManufacturerR.W. JOHNSON PHARM. RES. INST. USA/DIV. OF ORTHO PHARMACEUTICAL CORP.
Manufacturer Address920 U.S. RTE 202 P.O. BOX 300 RARITAN NJ 08869 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2001-03-22

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