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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCEPTUS, INC.ESSUREKNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

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CONCEPTUS, INC. ESSURE KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE   Back to Search Results
Model Number ESS 205
Event Date 12/07/2007
Event Type  Other   Patient Outcome  Required Intervention,Hospitalization
Event Description

This physician reported on 12/6/07, that he was going to remove the essure micro-inserts the next day due to persistent pain, this pt experienced after having them placed in 2007. The physician evaluated the pain with pelvic examinations which were normal, and a ct scan which showed the micro-inserts to be properly located within the respective fallopian tubes. A white blood cell count was normal. The day after surgery, he reported both micro-inserts were removed laparascopically without difficulty; they appeared normal in the right location without any inflammation. There was no pathology he could find to explain the pelvic pain. He performed a d&c, hysterectoscopy and laparoscopy. He reported to conceptus on 1/7/08 via fax, that during her post operative visit 2 weeks later, her symptoms were much improved and pain seemed to be resolved, but he would continue to monitor her. This physician feels the pain was essure related as he could not find any other pathology to explain her symptoms.

 
Manufacturer Narrative

Add'l info will be added if physician sends a pathology report info and any info from add'l post operative visits.

 
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Brand NameESSURE
Type of DeviceKNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
Manufacturer (Section F)
CONCEPTUS, INC.
mountain view CA
Manufacturer (Section D)
CONCEPTUS, INC.
mountain view CA
Manufacturer Contact
rachelle acuna-narvaez,associate
331 east evelyn avenue
mountain view , CA 94041
(650) 962 -4078
Device Event Key980399
MDR Report Key975862
Event Key922461
Report Number2951250-2008-00001
Device Sequence Number1
Product CodeKNH
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/07/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberESS 205
Device LOT Number623193
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
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? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/08/2008 Patient Sequence Number: 1
#TreatmentTreatment Date
NONE
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