MAUDE Adverse Event Report: HOLOGIC, INC. ADIANA PERMANENT CONTRACEPTION SYSTEM; CONTRACEPTIVE DEVICE

Catalog Number A1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Premature Labor (2465); Blood Loss (2597); Pregnancy (3193)

Event Date 01/11/2016

Event Type  Injury  

Manufacturer Narrative

Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.Internal reference complaint: (b)(4).

Event Description

This report pertains to the first of two hologic devices reported.See associated medwatch, manufacturer's report #1222780-2018-00220.It was reported by the patient maude event report (mw5079277), that pregnancy occurred four years after adiana implant and novasure endometrial ablation."rupture of amniotic membrane at (b)(6) gestion, birth at (b)(6), placenta increta resulting in emergency hysterectomy with massive blood loss." no additional information was received.

• Brand Name: ADIANA PERMANENT CONTRACEPTION SYSTEM
• Type of Device: CONTRACEPTIVE DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 7948141
• MDR Text Key: 123118745
• Report Number: 1222780-2018-00219
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2018
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention