MAUDE Adverse Event Report: SKLAR CORPORATION SKLAR CERVEX-BRUSH; SPATULA, CERVICAL, CYTOLOGICAL

Model Number 96-4140

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2023

Event Type  malfunction  

Event Description

The broom portion of the swab detached from the handle while the provider was performing a pap smear test.The broom was removed by the provider using forceps.No harm to the patient.

• Brand Name: SKLAR CERVEX-BRUSH
• Type of Device: SPATULA, CERVICAL, CYTOLOGICAL
• Manufacturer (Section D): SKLAR CORPORATION
• MDR Report Key: 17564363
• MDR Text Key: 321541865
• Report Number: MW5144654
• Device Sequence Number: 1
• Product Code: HHT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-4140
• Device Lot Number: 600014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female