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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSTEAD, INC.INSTEAD SOFTCUPFEMININE HYGIENE PROTECTION
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INSTEAD, INC. INSTEAD SOFTCUP FEMININE HYGIENE PROTECTION   Back to Search Results
Event Date 01/03/2005
Event Type  Other   Patient Outcome  Required Intervention
Event Description

Patient inserted the instead softcup in january 2005 and when they tried to remove it 6 hours later was unable to get it out. 14 hours later they were sitll unable to get it out and became dizzy and deviloped a migraine. They finally called the paramedics to take them to the hosital where they had the cup removed by the physcian.

 
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Brand NameINSTEAD SOFTCUP
Type of DeviceFEMININE HYGIENE PROTECTION
Manufacturer (Section F)
INSTEAD, INC.
4275 executive square
suite 1000
la jolla CA 92037 1478
Manufacturer (Section D)
INSTEAD, INC.
4275 executive square
suite 1000
la jolla CA 92037 1478
Manufacturer Contact
4275 executive square
la jolla , CA 92037
(NA)
Device Event Key573294
MDR Report Key583466
Event Key554538
Report Number3026654-2005-00003
Device Sequence Number1
Product CodeHHE
Report Source Manufacturer
Source Type Other
Reporter Occupation NOT APPLICABLE
Remedial Action Other
Type of Report Initial
Report Date 03/07/2005,03/10/2005
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2005
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/18/2005
Device Agena
Event Location Hospital
Date Report TO Manufacturer01/18/2005
Date Manufacturer Received01/18/2005
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/22/2005 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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