MAUDE Adverse Event Report: PURITAN MEDICAL PRODUCTS COMPANY LLC PURITAN HISTOBRUSH; CYTOLOGY BRUSH

Model Number 2199

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2016

Event Type  malfunction  

Manufacturer Narrative

We have a 5-year market history of (b)(4) cytology devices per year.This is the first report of a brush failure.The production records and reserve samples from the lot were normal.This report is entered in our trend analysis program and will be monitored for similar claims.

Event Description

The customer reports that the end of the cytology brush came off during a pap smear procedure.The doctor retrieved the brush.

• Brand Name: PURITAN HISTOBRUSH
• Type of Device: CYTOLOGY BRUSH
• Manufacturer (Section D): PURITAN MEDICAL PRODUCTS COMPANY LLC; 31 school street; po box 149; guilford ME 04443 0149
• Manufacturer Contact: william young ; 31 school street; po box 149; guilford, ME 04443-0149 ; 2078763311
• MDR Report Key: 5738558
• MDR Text Key: 47839356
• Report Number: 1216735-2016-00002
• Device Sequence Number: 1
• Product Code: HHT
• UDI-Device Identifier: 00609576250072
• UDI-Public: 0609576250072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: 2199
• Device Catalogue Number: 2199
• Device Lot Number: 18636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention