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 2019-10-16 for SINGLE USE GUIDWIRE OL-XA25455 manufactured by Terumo Corporation, Ashitaka.
| Report Number | 9681834-2019-00172 |
| MDR Report Key | 9197780 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-16 |
| Date of Report | 2019-10-16 |
| Date of Event | 2019-09-13 |
| Date Mfgr Received | 2019-09-18 |
| Device Manufacturer Date | 2019-03-19 |
| Date Added to Maude | 2019-10-16 |
| 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 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002837866 |
| 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 | SINGLE USE GUIDWIRE |
| Generic Name | ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY |
| Product Code | OCY |
| Date Received | 2019-10-16 |
| Returned To Mfg | 2019-09-24 |
| Model Number | NA |
| Catalog Number | OL-XA25455 |
| Lot Number | 190319 |
| 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 | 2019-10-16 |