MAUDE Adverse Event Report: COPAN ITALIA SPA FLOQSWABS

Model Number 519CS01.VER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/23/2022

Event Type  Injury  

Manufacturer Narrative

The following internal investigation was performed on catalogue # 519cs01.Ver, lot # 2110365: analysis of device history records: copan checked the internal records related to the manufacturing and controls before the release on the market of the reported product.No anomalies linked to the reported issue have been detected; historical data analysis: no other complaints of the same type were recorded on the finished lot # 2110365 which, according to copan's internal traceability, it was completely sold; sterilization process review: copan checked the documentation related to sterilization process and no anomalies have been detected; retains inspections: a visual inspection has been performed on copan's retains and the conformity of the product was confirmed.No further action is planned at this time since: the internal investigation does not confirm that the event is related to a defect or malfunction of the copan device; the event is a subject-specific reaction not predictable; the assessment of the biocompatibility studies shows evidence of no concerns and confirms the quality and safety of the product; the event is an isolated case.Copan will continue to monitor products for similar events.

Event Description

On 23rd feb 2022, copan received a call from a concerned parent whose child was swabbed using 519cs01.Ver."the (b)(6) child experienced some slight swelling around the eye, tear duct and nose.This may have been caused by an irritation from the swab itself however, the parent is concerned about a potential allergic reaction." on 28th feb 2022, copan contacted the (b)(6) (hospital where event occurred and for which the contact was provided) to send a form useful to retrieve more information on the event and patient condition.On 04th march 2022, the filled questionnaire was received by copan filled in by the medical assistant who was present during the event and the medical doctor.The following information has been retrieved: the sample collection site is the nose right side only, the purpose of the sampling was to investigate some sick symptoms (runny nose and cough), the medical doctor confirmed the allergic reaction and the causal relationship between the sample collection and allergic reaction, symptoms presented are right side only red, slight swelling around the eye, edema and rash surrounding the treated nostril, the allergic reaction occured after approximately 10 mins from sampling, the patient was treated with 5ml benadryl (antihistamines).

• Brand Name: FLOQSWABS
• Type of Device: FLOQSWABS
• Manufacturer (Section D): COPAN ITALIA SPA; via f. perotti 10; brescia, italy 25125 ; IT 25125
• Manufacturer (Section G): COPAN ITALIA SPA; via f. perotti 10; brescia, italy 25125 ; IT 25125
• Manufacturer Contact: stefania triva ; via f. perotti 10; brescia, italy 25125 ; IT 25125
• MDR Report Key: 13868902
• MDR Text Key: 293093610
• Report Number: 3002444944-2022-00001
• 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: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 519CS01.VER
• Device Catalogue Number: 519CS01.VER
• Device Lot Number: 2110365
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female