MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-07-08 for THINPREP 2000 SYSTEM PRESERVCYT 50 PACK 0234005 manufactured by Cytyc Corp..
[20244075]
A physician (allergist) reported that he was contacted by a pt that was compalining of headaches. Upon the physician's investigation into possible causes, the pt informed the physician that she worked in a lab and seems to get these headaches when exposed to preservcyt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-1998-00002 |
| MDR Report Key | 176217 |
| Report Source | 05 |
| Date Received | 1998-07-08 |
| Date of Report | 1998-07-01 |
| Date of Event | 1998-06-10 |
| Date Reported to FDA | 1998-07-01 |
| Date Mfgr Received | 1998-06-10 |
| Date Added to Maude | 1998-07-13 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP 2000 SYSTEM PRESERVCYT 50 PACK |
| Generic Name | CYTOLOGY SLIDE PREPARATION DEVICE |
| Product Code | KEW |
| Date Received | 1998-07-08 |
| Model Number | 0234005 |
| Catalog Number | 0234005 |
| Lot Number | NI |
| ID Number | NA |
| Operator | NO INFORMATION |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 171332 |
| Manufacturer | CYTYC CORP. |
| Manufacturer Address | 85 SWANSON RD. BOXBOROUGH MA 01719 US |
| Baseline Brand Name | THINPREP 2000 SYSTEM PRESERVCYT 50 PACK |
| Baseline Generic Name | CYTOLOGY SLIDE PREPARATION DEVICE |
| Baseline Model No | 0234005 |
| Baseline Catalog No | 0234005 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-08 |