MAUDE Adverse Event Report: PCR COVID-19 TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

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

Patient Problem Epistaxis (4458)

Event Date 01/15/2021

Event Type  Injury  

Event Description

I am allowed to visit my husband in a nursing home one or two times a week, but i must have proof of a negative pcr covid-19 test no more than 72 hours before my visit.Since (b)(6) i have been taking one or two tests each week, always the less invasive nasal test except for on (b)(6) when i had the nasal test that goes much higher up in the nasal passage.On (b)(6), while visiting my husband, i had an intense nose bleed in my right nostril, flowing for about 25 minutes before slowing down at all.Since i had a history of such nose bleeds happening every few years (for no apparent reason), once having to be hospitalized because of being unable to stop the bleed, i attributed the (b)(6) bleed to random incident.However, on (b)(6), the morning after having the more invasive pcr test, i had another long-lasting nose bleed (in the right nostril, although the test was done only in the left nostril).I had another briefer nose bleed on (b)(6).I now suspect that the frequent pcr tests are causing these bleeds.Fda safety report id # (b)(4).

• Brand Name: PCR COVID-19 TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 11207300
• MDR Text Key: 228210920
• Report Number: MW5098894
• Device Sequence Number: 1
• Product Code: QJR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 59