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

Model Number QS-0025

Device Problem Biocompatibility (2886)

Patient Problem Local Reaction (2035)

Event Date 11/23/2020

Event Type  Injury  

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 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
• Type of Device: QUANTISAL ORAL FLUID COLLECTION DEVICE 25 PK
• Manufacturer (Section D): STATSURE DIAGNOSTIC SYSTEMS; 1337 east 9 street; brooklyn NY 11230
• Manufacturer (Section G): STATSURE DIAGNOSTICS; 1337 east 9 street; brooklyn NY 11230
• Manufacturer Contact: mo bodner ; 1337 east 9 street; brooklyn, NY 11230 ; 9174174489
• MDR Report Key: 11050997
• MDR Text Key: 223148002
• Report Number: 3008264082-2020-00001
• Device Sequence Number: 1
• Product Code: PJD
• UDI-Device Identifier: 00840937112151
• UDI-Public: 00840937112151
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K200801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: QS-0025
• Device Catalogue Number: QS-0025
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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