MAUDE Adverse Event Report: METAL ECC BRUSH; SPATULA, CERVICAL, CYTOLOGICAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Burning Sensation (2146); Reaction (2414); Ambulation Difficulties (2544)

Event Date 08/12/2020

Event Type  Injury  

Event Description

Endocervical curettage and colposcopy performed with the following ointment application.Please read info in the comments below.I had a colposcopy with the brush ecc and cervical biopsy performed by dr.B)(6).It was 8/10 pain after the "iron ointment was applied" and i felt strongest burning sensation what made me ask doctor right away if i am allowed to douche at home with tea tree oil, baking soda or something that i could tell would make the burning go away, but i was told no.I couldn't sit, walk or even stand from the pain even though doctor didn't warn me of such reaction.I called nurse line in the morning.They recommended to take benadryl and 800 ibuprofen.A gyn nurse called later and named the ointment.I researched and everything made sense.Besides pelvic and vaginal pain and burning sensation i had stabbing chest pain, and tachycardia 100 bpm.My blood pressure was 94/60.I still was not allowed to douche, so i stay in my bed with my legs wide open as access of air to vagina is easing the pain.Metal ecc brush with following med gyn monsels solution per the nurse whom i spoke on (b)(6).Fda safety report id# (b)(4).

• Brand Name: METAL ECC BRUSH
• Type of Device: SPATULA, CERVICAL, CYTOLOGICAL
• MDR Report Key: 10419948
• MDR Text Key: 203506540
• Report Number: MW5096111
• Device Sequence Number: 1
• Product Code: HHT
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 79