MAUDE Adverse Event Report: COPAN DIAGNOSTICS, INC. FLOQSWAB; APPLICATOR, ABSORBENT TIPPED, STERILE

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 12/28/2017

Event Type  malfunction  

Event Description

While swabbing the patient's right nostril with a flu swab using appropriate technique, upon removing the swab from the nostril, it was noticed that the end of the swab broke off in the patient's nose and remained in the nostril.Patient was instructed to blow out the nose in an attempt to remove the swab.Upon examination, no foreign body was noted or able to be retrieved.Patient was sent to an ent and the swab was retrieved by the ent.

• Brand Name: FLOQSWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): COPAN DIAGNOSTICS, INC.; 26055 jefferson avenue; murrieta CA 92562
• MDR Report Key: 7218297
• MDR Text Key: 98212429
• Report Number: 7218297
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2018
• Device Age: 0 YR
• Event Location: Other
• Date Report to Manufacturer: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Outcome(s): Other
• Patient Age: 16 YR