CAYA NDC 63704-020-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for CAYA NDC 63704-020-01 manufactured by Kessel Medintim Gmbh.

Event Text Entries

[139541698] I was prescribed a caya diaphragm, and i noticed an error on the packing. The outer box states, "leave in the vaginal for longer than 24 hours without interruption. " the packaging insert, however, states in highlighted, bold text: "the caya diaphragms should never be left in the vagina for longer than 24 hours [underline] without interruption. Wearing it for longer, uninterrupted periods can promote bacterial growth in the vagina. These bacteria could lead to toxic shock syndrome. " please ask the makers of caya to fix the verbiage on the outer box.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085042
MDR Report Key8436589
Date Received2019-03-19
Date of Report2019-03-18
Date of Event2019-03-17
Date Added to Maude2019-03-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCAYA
Generic NameDIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES)
Product CodeHDW
Date Received2019-03-19
Model NumberNDC 63704-020-01
Lot Number17U107L04/A
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerKESSEL MEDINTIM GMBH


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-19

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