MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-09-03 for THINPREP SYSTEM TP-2000 70031-001 manufactured by Cytyc Corp..
[98149]
The patient received a pap test (type unknown) on 12/24/97, which was classified as "agus". The primary medical doctor referred the patient to the ob/gyn who reported this adverse event to cytyc. The ob/gyn requested a thinprep pap test which was performed on 1/19/98. The diagnosis was deemed to be class ii reactive repairative changes. The patient was called back in by the ob/gyn and a biopsy was performed on 1/29/98 because the cervix was bleeding on touch. The biopsy revealed an invasive, poorly-differentiated, squamous carcinoma. Radical surgery was performed. All indications, based on cytyc's investigation into this issue, are that the thinprep system did perform as intended and that there is no information that "reasonably suggests" that it malfunctioned. Cytyc corporation does not believe that the incident reported by the reporting ob/gyn is sufficient to indicate that the thinprep system failed to perform per its intended design. Due to the fact, however, that cytyc cannot, without certainty, determine that the instrument did perform correctly, a decision has been made to issue a mdr to the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-1998-00003 |
| MDR Report Key | 186194 |
| Report Source | 05 |
| Date Received | 1998-09-03 |
| Date of Report | 1998-09-02 |
| Date of Event | 1998-02-20 |
| Date Added to Maude | 1998-09-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAN BRACCO |
| Manufacturer Street | 85 SWANSON ROAD |
| Manufacturer City | BOXBOROUGH MA 01719 |
| Manufacturer Country | US |
| Manufacturer Postal | 01719 |
| Manufacturer Phone | 9782663103 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP SYSTEM |
| Generic Name | CYTOLOGY SLIDE PREPARATION DEVICE |
| Product Code | IFB |
| Date Received | 1998-09-03 |
| Model Number | TP-2000 |
| Catalog Number | 70031-001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 180981 |
| Manufacturer | CYTYC CORP. |
| Manufacturer Address | 85 SWANSON RD. BOXBOROUGH MA 01719 US |
| Baseline Brand Name | THINPREP 2000 PROCESSOR |
| Baseline Generic Name | CYTOLOGY SLIDE PREP.DEV. |
| Baseline Model No | TP-2000 |
| Baseline Catalog No | 70031-001 |
| Baseline ID | NA |
| Baseline Device Family | THINPREP PROCESSOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P9500 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-09-03 |