MAUDE Adverse Event Report: STATSURE DIAGNOSTIC SYSTEMS QUANTISAL; QUANTISAL ORAL FLUID COLLECTION DEVICE 25 PK

Model Number	QS-0025
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although this incident occurred in (b)(6), under mir.Immunalysis assessed it as mdr reportable as the same sku (qs-0025) is marketed in the us.Investigation is ongoing and follow up report will be submitted.
Event or Problem Description
It was reported on 18-nov-2020, that a patient underwent workplace drug testing on (b)(6) 2020, with a quantisal¿ oral fluid collection device (part # qs-0025, lot #unknown) and suffered an allergic reaction.Initially, the event was assessed as non-reportable, as their was no mention of medical intervention.Additional information was received on 23-nov-2020 (awareness date), indicating the donor's allergic reaction required contact with their dermatologist and involved the donor experiencing a swollen eyelid, rosacea of the eyes, and complete numbness in the area between the upper lip and nose.Donor contact with their dermatologist was made the day after the incident, on (b)(6) 2020.Donor mentioned suspicion of quantisal as the cause of the allergic reaction.However, donor mentioned that they are allergic to many things.The donor's symptoms subsided and eventually disappeared.Donor fully recovered and no additional medical intervention was required.In an abundance of caution, it was decided to report this incident as an mdr.

• Brand Name: QUANTISAL
• Common Device Name: QUANTISAL ORAL FLUID COLLECTION DEVICE 25 PK
• Manufacturer (Section D): STATSURE DIAGNOSTIC SYSTEMS; 1337 east 9 street; brooklyn NY 11230
• MDR Report Key: 11050997
• Report Number: 3008264082-2020-00001
• Device Sequence Number: 19577002
• Product Code: PJD
• UDI-Device Identifier: 00840937112151
• UDI-Public: 00840937112151
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K200801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: QS-0025
• Device Catalogue Number: QS-0025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other