MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-01-22 for TISSUE-TEK VIP6 VACUUM INFILTRATION PROCESSOR, 115 V, 60 HZ 6032 manufactured by Sakura Seiki Co., Ltd..
| Report Number | 2083544-2020-00001 |
| MDR Report Key | 9618521 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-22 |
| Date of Event | 2019-12-24 |
| Date Mfgr Received | 2019-12-30 |
| Date Added to Maude | 2020-01-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SOLMAZ SHAIDA |
| Manufacturer Street | 1750 WEST 214TH STREET |
| Manufacturer City | TORRANCE 90501 |
| Manufacturer Country | US |
| Manufacturer Postal | 90501 |
| Manufacturer Phone | 3109727800 |
| Manufacturer G1 | SAKURA SEIKI CO., LTD. |
| Manufacturer Street | 75-5, IMOJIYA |
| Manufacturer City | CHIKUMA, 387-0015 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 387-0015 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TISSUE-TEK VIP6 VACUUM INFILTRATION PROCESSOR, 115 V, 60 HZ |
| Generic Name | VIP6 |
| Product Code | IEO |
| Date Received | 2020-01-22 |
| Model Number | 6032 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAKURA SEIKI CO., LTD. |
| Manufacturer Address | 75-5, IMOJIYA CHIKUMA, 387-0015 JA 387-0015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-22 |