MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD RAPID DETECTION OF SARS-COV-2 VERITOR¿; CORONAVIRUS ANTIGEN DETECTION SYSTEM

Catalog Number 256082

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

Eua # (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported while testing for sars-cov-2 an allergic reaction occurred after the sample was collected.Included a burning nose, sneezing, watering eyes and hives occurring on the chest and hands.Patient did not seek medical attention but did self-treat by taking zyrtec and pepcid, which alleviated the reaction.Eua # (b)(4).

Event Description

It was reported while testing for sars-cov-2 an allergic reaction occurred after the sample was collected.Included a burning nose, sneezing, watering eyes and hives occurring on the chest and hands.Patient did not seek medical attention but did self-treat by taking zyrtec and pepcid, which alleviated the reaction.Eua # (b)(4).

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 3006948883-2021-00225 was sent in error.Patient did not seek treatment for the allergic reaction, symptoms were alleviated by patient self-treating with zyrtec and pepcid, therefore, this is not considered to be a serious injury.

• Brand Name: BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
• Type of Device: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11315999
• MDR Text Key: 231592577
• Report Number: 3006948883-2021-00225
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

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: Other
• Device Expiration Date: 03/18/2021
• Device Catalogue Number: 256082
• Device Lot Number: 0285008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other