MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-05 for TISSUE PATH CASSETTE IV * 22-272420 manufactured by Richard Allan Scientific.
[72630]
Dr did biopsy on pt. Cassette with specimen failed. Specimen was lost.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 137209 |
| MDR Report Key | 137209 |
| Date Received | 1997-12-05 |
| Date of Report | 1997-12-03 |
| Date of Event | 1997-10-15 |
| Date Facility Aware | 1997-10-15 |
| Report Date | 1997-12-03 |
| Date Added to Maude | 1997-12-11 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TISSUE PATH CASSETTE IV |
| Generic Name | * |
| Product Code | IDZ |
| Date Received | 1997-12-05 |
| Model Number | * |
| Catalog Number | 22-272420 |
| Lot Number | 97G30 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 134024 |
| Manufacturer | RICHARD ALLAN SCIENTIFIC |
| Manufacturer Address | 225 PARSONS ST KALAMAZOO MI 490073538 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-12-05 |