MAUDE Adverse Event Report: QIAGEN SCIENCES, LLC DIGENE® HC2 DNA COLLECTION DEVICE; SPATULA, CERVICAL, CYTOLOGICAL

Catalog Number 5126-1220

Device Problem Insufficient Information (3190)

Patient Problem Syncope/Fainting (4411)

Event Date 11/21/2022

Event Type  Injury  

Manufacturer Narrative

A patient experience syncope during collection procedure and was treated by the attending physician.Patient was discharged and reported no discomfort.Physician reported the most likely cause for patient fainting was patient not having breakfast as well as being nervous.There was no report of device malfunction or defect from the facility.

Event Description

Patient fainted during sampling procedure with hc2 dna collection device.

• Brand Name: DIGENE® HC2 DNA COLLECTION DEVICE
• Type of Device: SPATULA, CERVICAL, CYTOLOGICAL
• Manufacturer (Section D): QIAGEN SCIENCES, LLC; 19300 germantown road; germantown MD 20874
• Manufacturer (Section G): QIAGEN SCIENCES, LLC; 19300 germantown road; germantown MD 20874
• Manufacturer Contact: donna sowers ; 19300 germantown road; germantown, MD 20874 ; 2406867876
• MDR Report Key: 16157358
• MDR Text Key: 307281224
• Report Number: 1122376-2023-00001
• Device Sequence Number: 1
• Product Code: HHT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 5126-1220
• Device Lot Number: M2309
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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