• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION Back to Search Results
Model Number ESS305
Event Date 01/01/2013
Event Type  Injury  
Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

 
Event Description

This is a spontaneous case report received from a female consumer of unspecified age via regulatory authority (case# mw5036798) in united states on (b)(6)-2014 who had essure (fallopian tube occlusion insert) inserted. On (b)(6)-2011, essure was inserted. In 2012, she became pregnant (please refer to mother´s case (b)(6)). In 2013, she had to deliver her son, but he had already died in utero three to four days prior. In 2013, she went back in for surgery to have fallopian tubes removed. Upon awakening she was informed the essure on one side had migrated and perforated her uterus with a possibility of later puncturing her bowel. Therefore, she needed a hysterectomy. She went back under to have the hysterectomy, however leaving ovaries. Three days later she was back in the hospital with a fever of 103. Nothing came of the fever. The date (b)(6)-2013 was reported as explant date. Death and life-threatening were selected by consumer as event report type and event outcome, respectively. However, it was not specified which event. No further information was provided. Ptc investigation result was received on (b)(6)-2014. This adverse event report is related to a product technical complaint (ptc). (b)(4). Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint. Typically, we would inspect the micro-insert to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies. Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record. We are unable to confirm any quality defect or device malfunction at this time. Medical assessment: the reported events are not indicative of a quality defect per se. No batch number was reported. Without this information neither a technical batch evaluation nor a batch signal cluster review in the (b)(6) database for a more detailed statistical medical evaluation is possible. No complaint sample was provided for further technical investigation. In summary, there is no suspicion of a quality defect based on the limited available information. Company causality comment: this non-medically confirmed, spontaneous case report was received from a female consumer and refers to her son who had essure micro-insert exposure in utero and his mother had to deliver him, who died in utero three to four days prior. The event i had to deliver son died in utero three to four days prior interpreted as fetal death was considered serious and incident due to death and it is unlisted according to the reference safety information for essure. In this particular case, it was reported that consumer's son died in utero; no information about the exact cause of fetal death was provided; however considering that a delivery was reported (implying a advanced gestational age at time of event) a mechanical interference between essure and the developing pregnancy cannot be excluded and this event was, therefore considered as related to the suspect insert. According to and product technical analysis, no complaint sample was provided for further technical investigation. In summary, there is no suspicion of a quality defect based on the limited available information. No further information is expected.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameESSURE
Type of DeviceINSERT, TUBAL OCCLUSION
Manufacturer (Section D)
BAYER PHARMA AG
müllerstr. 178
berlin, CA 13353
GERMANY 13353
Manufacturer (Section G)
BAYER PHARMA AG
müllerstr. 178
berlin, CA 13353
GERMANY 13353
Manufacturer Contact
k shaw lamberson
100 bayer blvd.
p.o. box 915
whippany , NJ 07981-0915
MDR Report Key4051640
Report Number2951250-2014-00351
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Source Type Other,Consumer,CONSUMER,OTHER
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberESS305
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2014
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/02/2014 Patient Sequence Number: 1
-
-