MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-11 for SUPER SHEATH IS0724 manufactured by Togo Medikit Co. Ltd..
| Report Number | 9612126-2020-00003 |
| MDR Report Key | 9693130 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-11 |
| 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 | YASHASWINI PATWARDHAN |
| Manufacturer Street | AMSELWEG 5 |
| Manufacturer City | RHEDA-WIEDENBRUECK, 33378 |
| Manufacturer Country | GM |
| Manufacturer Postal | 33378 |
| Manufacturer G1 | TOGO MEDIKIT CO. LTD. |
| Manufacturer Street | 17148-6 AZA KAMEKAWA OAZA HICHIYA |
| Manufacturer City | HYUGA CITY, 883-0062 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 883-0062 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER SHEATH |
| Generic Name | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | DRE |
| Date Received | 2020-02-11 |
| Catalog Number | IS0724 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOGO MEDIKIT CO. LTD. |
| Manufacturer Address | 17148-6 AZA KAMEKAWA OAZA HICHIYA HYUGA CITY, 883-0062 JA 883-0062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-11 |