MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-06-12 for DAKOLINK TISSUE CASSETTES DL200 manufactured by Dako North America, Inc..
[16838182]
Lip tissue sample was placed in tissue cassette for processing. The problem occurred during the formalin fixation step, which consists of the cassettes being placed in the retort chamber of the sakura vip5 tissue processor set at 45 degrees c with slight agitation under vacuum and pressure. Cassettes are set in racks that fit the chamber with nine cassettes per space, allowing room between cassettes for the reagent to flow freely. During this step, the cassette opened and the sample fell out. The sample could no longer be identified and no add'l tissue was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022180-2009-00002 |
| MDR Report Key | 1403331 |
| Report Source | 06 |
| Date Received | 2009-06-12 |
| Date of Report | 2009-06-05 |
| Date of Event | 2009-05-28 |
| Date Added to Maude | 2011-03-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KELLY MILLER |
| Manufacturer Street | 6392 VIA REAL |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8055666655 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAKOLINK TISSUE CASSETTES |
| Generic Name | TISSUE CASSETTES |
| Product Code | IDZ |
| Date Received | 2009-06-12 |
| Model Number | NA |
| Catalog Number | DL200 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAKO NORTH AMERICA, INC. |
| Manufacturer Address | CARPINTERIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-06-12 |