MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE REACH; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 10-401FC

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

Patient Problem Rash (2033)

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are 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.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.

Event Description

It was reported that a patient received a myosure procedure for a polypectomy on (b)(6) without complications and that received a novasure procedure on the same date.It was reported the following timeline, on (b)(6) the patient received a myosure procedure then a novasure ablation.On (b)(6), it was reported that the patient experienced abdominal pain for which the physician administered cephalexin for a uti, that was followed by rash and itching.On (b)(6) the patient received a short course of prednisolone for 3 days.Later the patient went to the emergency room on (b)(6) in which it was observed that her heart rate was elevated.On (b)(6) the patient went to the cardiologist and her heart rate was again elevated, stress tests were conducted.On april 20th the patient went to the dermatologist complaining of rash/hives on her stomach and on may 18th started a new course of prednisone for 5 days.On (b)(6) patient was off the prednisone and the rash returned for which she tried betamethasone cream.On (b)(6) the patient went back to using prednisone and on (b)(6) the patient was referred to an allergist who prescribed allegra and zyrtec.The patient keeps with her symptoms and has seen an allergist, dermatologist, rheumatologist, and no etiology for her symptoms has been able to be determined.Patient received moderna vaccine on (b)(6) and (b)(6).

• Brand Name: MYOSURE REACH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 12980991
• MDR Text Key: 284903964
• Report Number: 1222780-2021-00365
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2021
• 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
• Treatment: NOVASURE NS2013
• Patient Outcome(s): Other
• Patient Sex: Female