MAUDE Adverse Event Report: TYPENEX SPECIMEN COLLECTION SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE

Lot Number 062820

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/26/2020

Event Type  Injury  

Event Description

Covid test swab tip broke and was lodged in the patient's nares.Physician was able to remove tip without problems.(b)(4).Fda safety report id# (b)(4).

• Brand Name: TYPENEX SPECIMEN COLLECTION SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• MDR Report Key: 10599214
• MDR Text Key: 209153657
• Report Number: MW5096909
• Device Sequence Number: 1
• Product Code: KXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2023
• Device Lot Number: 062820
• Was Device Available for Evaluation?: Yes
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR