MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-04 for PAP SMEAR SLIDE HOLDER * manufactured by Cytolabs.
[401162]
Cytolabs recently changed to a new slide holder. Rptr had never had a problem until these new slide holders. Rptr has had 4 shattered in transit since event date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035094 |
| MDR Report Key | 588473 |
| Date Received | 2005-04-04 |
| Date of Report | 2005-03-22 |
| Date of Event | 2005-02-24 |
| Date Added to Maude | 2005-04-08 |
| 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 | 3 |
| 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 |
| Brand Name | PAP SMEAR SLIDE HOLDER |
| Generic Name | SLIDE HOLDER |
| Product Code | KEW |
| Date Received | 2005-04-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 578324 |
| Manufacturer | CYTOLABS |
| Manufacturer Address | * SAN ANTONIO TX * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-04 |