MAUDE Adverse Event Report: HARDY DIAGNOSTICS COVID COLLECTION SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE

Lot Number 20200515

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/20/2020

Event Type  Injury  

Event Description

A 5cm covid collection swab broke off in left nostril.Sent to ent for removal.Fda safety report id# (b)(4).

• Brand Name: COVID COLLECTION SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): HARDY DIAGNOSTICS
• MDR Report Key: 10239051
• MDR Text Key: 197922977
• Report Number: MW5095375
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 20200515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2020
• 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: 65 YR