MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-06-19 for LIQUID COVERSLIP (LCS) 250-009 manufactured by Ventana Medical Systems, Inc..
[20763680]
Technician at site identified allergic reaction to liquid coverslip at an earlier date and has worn gloves since when coming into contact with reagent. Allergic response appeared to increase over time and was removed from the responsibities that would necessitate interaction with the chemical.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028492-2003-00002 |
| MDR Report Key | 467620 |
| Report Source | 07 |
| Date Received | 2003-06-19 |
| Date of Report | 2003-06-18 |
| Date of Event | 2003-05-30 |
| Date Mfgr Received | 2003-05-30 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2003-06-26 |
| 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 | 0 |
| Manufacturer Contact | SAM RUA, DIRECTOR |
| Manufacturer Street | * |
| Manufacturer City | TUCSON AZ 85737 |
| Manufacturer Country | US |
| Manufacturer Postal | 85737 |
| Manufacturer Phone | 5202293911 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIQUID COVERSLIP (LCS) |
| Generic Name | ACCESSORY REAGENT |
| Product Code | MVU |
| Date Received | 2003-06-19 |
| Model Number | NA |
| Catalog Number | 250-009 |
| Lot Number | 23489B |
| ID Number | * |
| Device Expiration Date | 2004-08-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 456545 |
| Manufacturer | VENTANA MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 1910 INNOVATION PARK DR. TUCSON AZ 85737 US |
| Baseline Brand Name | LIQUIED COVERSLIP (LCS) |
| Baseline Generic Name | ACCESSORY REAGENT |
| Baseline Model No | NA |
| Baseline Catalog No | 250-009 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2003-06-19 |