MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for RADIFOCUS INTRODUCER RR-A70K10AH manufactured by Terumo Corporation, Ashitaka.
| Report Number | 9681834-2020-00042 |
| MDR Report Key | 9876675 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-10-29 |
| Date Added to Maude | 2020-03-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | THERESA MUSSAW |
| Manufacturer Street | REG. NO. 2243441 950 ELKTON BLVD |
| Manufacturer City | ELKTON, MD |
| Manufacturer Country | US |
| Manufacturer Phone | 2837866718 |
| Manufacturer G1 | TERUMO CORPORATION, ASHITAKA |
| Manufacturer Street | REG. NO. 9681834 150 MAIMAIGI-CHO |
| Manufacturer City | FUJINOMIYA CITY, 418 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 418 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIFOCUS INTRODUCER |
| Generic Name | INTRODUCER, CATHETER |
| Product Code | DYB |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-06 |
| Model Number | NA |
| Catalog Number | RR-A70K10AH |
| Lot Number | 191029 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CORPORATION, ASHITAKA |
| Manufacturer Address | 150 MAIMAIGI-CHO FUJINOMIYA CITY, 418 JA 418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |