MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-30 for THERMO SCIENTIFIC TISSUE-LOC HISTOSCREEN C-0250-GR N/A manufactured by Richard Allan Scientific.
[94276862]
Thermo scientific? Tissue-loc? Histoscreen? Cassettes are used for handling small biopsies and fragile specimens. The unique design provides an inner chamber lined with a "see-through" mesh for easy identification of specimens. They eliminate the need for messy sponges or lens papers. Tissue-loc histoscreen cassettes are available in bulk packaging and in tubes intended for high throughput printing. The customer complained that the screen on the tissue-loc cassette was defective. This caused tissue to be lost during processing.
Patient Sequence No: 1, Text Type: N, H10
[94276863]
The customer claimed that the screen on the lid of the tissue-loc cassette was defective. This caused tissue to be lost during processing of the tissue and the patient had to be rebiopsied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1831638-2017-00001 |
| MDR Report Key | 7071353 |
| Date Received | 2017-11-30 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-02-21 |
| Date Mfgr Received | 2017-02-21 |
| Device Manufacturer Date | 2014-01-16 |
| Date Added to Maude | 2017-11-30 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BOWERMAN |
| Manufacturer Street | 4488 CAMPUS DRIVE |
| Manufacturer City | KALAMAZOO MI 49008 |
| Manufacturer Country | US |
| Manufacturer Postal | 49008 |
| Manufacturer Phone | 2695445625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERMO SCIENTIFIC TISSUE-LOC HISTOSCREEN |
| Generic Name | THERMO SCIENTIFIC TISSUE-LOC HISTOSCREEN |
| Product Code | IDZ |
| Date Received | 2017-11-30 |
| Model Number | C-0250-GR |
| Catalog Number | N/A |
| Lot Number | 103710 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD ALLAN SCIENTIFIC |
| Manufacturer Address | 4481 CAMPUS DRIVE KALAMAZOO MI 49008 US 49008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-30 |