THIN PREP *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-07 for THIN PREP * manufactured by Cytyc Corp..

Event Text Entries

[146408] Rptr states: false claims made by cytyc rep about the autocyte instrument. 1. They claim or give the impression that the cytyc instrument has been certified as significantly more effective than the autocyte instrument. 2. They claim that there are higher reimbursement rates for cytyc paps than for autocyte. 3. They told physicians that there is a high cross contamination in the autocyte method because the prep tech has to stick her fingers in the vial to remove the brush. 4. They claim autocyte has only partial approval from the fda. 5. They have maligned our lab & pathologists telling our accounts that we purchased a piece of junk & that our pathologists were incompetent. 6. They visited all our accounts & when they wouldn't convert to cytyc their sales rep went first to the head of the ob/gyn dept of the medical school, then to the head of the gyn oncology dept & then to the medical school dean. We have spent hours trying to undo & explain all of the misinformation they have disseminated.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017881
• MDR Report Key: 257878
• Date Received: 2000-01-07
• Date of Report: 2000-01-07
• Date of Event: 1999-08-01
• Date Added to Maude: 2000-01-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: THIN PREP
• Generic Name: PAP SMEAR PREP. INSTRUMENT
• Product Code: IFB
• Date Received: 2000-01-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 249722
• Manufacturer: CYTYC CORP.
• Manufacturer Address: 85 SWANSON RD. BOXBOROUGH MA 01719 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-01-07