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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEST SPECIMEN COLLECTION SWAB NP SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE
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NEST SPECIMEN COLLECTION SWAB NP SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE Back to Search Results
Lot Number 050320B01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)
Event Date 06/22/2020
Event Type  Injury  
Event Description
Using nest swabs for weekly covid testing in snf.After a few weeks of testing noting nose bleeds with some staff post testing.One staff member had a clinically significant nose bleed with inability to control with normal intervention (pressure, ice, packing).Staff member with uncontrolled and sustained nose bleeds went to the er on (b)(6) 2020.Er doctor implemented cauterization.Cauterization method not successful.On (b)(6) 2020 staff member went for ent consult for continued uncontrolled nose bleed.Dx multiple nasal cavity / nasopharynx lacerations requiring emergency surgical repair by ent.Staff member required same day surgery under general anesthesia.Exact lot and sample number of the swab causing injury was not retained, however supply of same type of swab remain in house, and photo of the swab type and identifying information provided.Nest, us.Fda safety report id# (b)(4).
 
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Brand Name
NEST SPECIMEN COLLECTION SWAB NP SWAB
Type of Device
APPLICATOR, ABSORBENT TIPPED, STERILE
MDR Report Key10249989
MDR Text Key198309334
Report NumberMW5095425
Device Sequence Number1
Product Code KXG
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/01/2022
Device Lot Number050320B01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age61 YR
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