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

Model Number	QS-0025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Blister (4537)
Date of Event	08/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 07-aug-2023, it was reported that the inside of a patient's mouth developed blisters both inside and out of the mouth.This occurred 1 day after use of an oral fluid collection device.Upon observation, a medical provider noted that the patient's ailment appeared to be fever blisters.As a result, the patient was prescribed medicated mouthwash to help with the pain.There were no noted issues or anomalies during the oral fluid collection process, and the collection site was unaware of any patient allergies.Three attempts for additional information have been made.No response has yet been received.
Additional Manufacturer Narrative
A review of the batch record for the affected kit lot (ek20987) found that there were no noted deviations or anomalies noted during the manufacturing of this lot.This lot was also confirmed to be within its established shelf life at the time of use.A historical search of complaints and quality incidents found no other incidents related to lot ek20987.Lot ek20987 was made using stem/pad lots 21110008 and 21110064.A total of (b)(4) units for lot 21110008 were manufactured in october 2021, and a total of (b)(4) units were manufactured in november 2021.There are no remaining quantities for either lot on site.In addition to ek20987, we determined that stem/pad lots 21110008 and 21110064 were also part of 6 additional quantisal kit lots.The manufacturer (statsure diagnostic systems) was contacted to inquire as to whether any anomalies were observed during the manufacturing process of the impacted lots.Statsure was able to confirm that no anomalies were observed.In 2020, cytotoxicity and intracutaneous (intradermal) reactivity testing for quantisal was performed.The test results showed that quantisal is safe when used according to the device's intended purpose and that the overall risk for biological safety is acceptable.The product met the requirements of iso 10993-1:2009.In 2021, maximization testing for four quantisal lots was performed.The study was performed according to iso 10993-10 guidelines.Both the stem & pad of the quantisal lots provided were extracted in saline and cottonseed oil.Thereafter, 34 guinea pigs were tested and exposed intra-dermally to the quantisal extracts.All animals were observed for adverse reactions.No sensitization reactions were observed in test animals.Materials utilized for quantisal are generally recognized as safe.The swab that comes in contact with the patient is comprised of untreated cellulose and the stem is polypropylene.

• Brand Name: QUANTISAL
• Common Device Name: ORAL FLUID COLLECTION DEVICE
• Manufacturer (Section D): STATSURE DIAGNOSTIC SYSTEMS; 1337 east 9 street; brooklyn NY 92121
• Manufacturer (Section G): STATSURE DIAGNOSTICS; 1337 east 9th street; brooklyn 11230
• Manufacturer Contact: mo bodner ; 1337 east 9 street; brooklyn, NY 92121 ; 9174174489
• MDR Report Key: 17676612
• Report Number: 3008264082-2023-00001
• Device Sequence Number: 17971628
• Product Code: PJD
• UDI-Device Identifier: 00840937105078
• UDI-Public: 00840937105078
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K942435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2023

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 Expiration Date: 11/30/2023
• Device Model Number: QS-0025
• Device Catalogue Number: QS-0025
• Device Lot Number: EK20987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female