MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE TISSUE REMOVAL DEVICE; UTERINE TISSUE REMOVAL DEVICE

Model Number 10-401

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

Patient Problem Unspecified Infection (1930)

Event Date 04/10/2019

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.(b)(4).

Event Description

This report pertains to the first of two hologic devices used in the same procedure.See associated medwatch, manufacturer's report # 1222780-2019-00109.It was reported that on (b)(6) 2019 a myosure tissue removal and novasure endometrial ablation were performed.On (b)(6) 2019 the patient presented to the emergency room with malodorous discharge, fever, and chills with a temperature of 102°f and uterine tenderness on examination.Her abdominal exam was negative for peritoneal signs.Her wbc count was 18,000 and a ct-scan demonstrated a 4cm fluid collection within the uterine cavity and a possible tubo-ovarian abcess along with thickened bowel wall.There was no suspicion for bowel perforation.The patient was admitted to the hospital and started on broad-spectrum antibiotics and an ultrasound was obtained.

• Brand Name: MYOSURE TISSUE REMOVAL DEVICE
• Type of Device: UTERINE TISSUE REMOVAL DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 8590335
• MDR Text Key: 144395015
• Report Number: 1222780-2019-00108
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-401
• Device Catalogue Number: 10-401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention