MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-23 for SOLO PLUS HYBRID GUIDEWIRE HW35SS manufactured by Heraeus Medical Components, Llc.
| Report Number | 2315342-2019-00004 |
| MDR Report Key | 9227263 |
| Date Received | 2019-10-23 |
| Date of Report | 2019-10-23 |
| Date Mfgr Received | 2019-09-23 |
| Device Manufacturer Date | 2019-07-09 |
| Date Added to Maude | 2019-10-23 |
| 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 | CHELSEA BECKER |
| Manufacturer Street | 2605 FERNBROOK LANE N SUITE J |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7632526500 |
| Manufacturer G1 | HERAEUS MEDICAL COMPONENTS, LLC |
| Manufacturer Street | 2605 FERNBROOK LANE N SUITE J |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SOLO PLUS HYBRID GUIDEWIRE |
| Generic Name | STYLET FOR CATHETER, GASTRO-UROLOGY |
| Product Code | EZB |
| Date Received | 2019-10-23 |
| Catalog Number | HW35SS |
| Lot Number | PL06804 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS MEDICAL COMPONENTS, LLC |
| Manufacturer Address | 2605 FERNBROOK LANE NORTH SUITE J PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-10-23 |