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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TYPENEX MEDICAL LLC SPECIMEN COLLECTION SWAB NASOPHARYNGEAL; APPLICATOR, ABSORBENT TIPPED, STERILE
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TYPENEX MEDICAL LLC SPECIMEN COLLECTION SWAB NASOPHARYNGEAL; APPLICATOR, ABSORBENT TIPPED, STERILE Back to Search Results
Model Number SW0102
Device Problems Break (1069); Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  malfunction  
Event Description
Patient was being tested for covid, and speciman collection swab broke off at the score line while still in his nose.Patient was seen by provider that was in the clinic and swab was easily removed with sterile forceps.Patient stated that he was feeling well after and specimen was collected.It was reported they received new swabs that are "paper" not plastic.While they are easier to break into the testing tube, these new swabs bend very easy.Writer opened swab and applied little to no pressure above the scoring and broke easily.This appears to be an equipment issue verses an operator.
 
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Brand Name
SPECIMEN COLLECTION SWAB NASOPHARYNGEAL
Type of Device
APPLICATOR, ABSORBENT TIPPED, STERILE
Manufacturer (Section D)
TYPENEX MEDICAL LLC
303 e. wacker drive
suite 1030
chicago IL 60601
MDR Report Key11805280
MDR Text Key249960341
Report Number11805280
Device Sequence Number1
Product Code KXG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSW0102
Device Catalogue NumberSW0102
Device Lot Number062820
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/05/2021
Event Location Other
Date Report to Manufacturer05/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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