MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-27 for PORTIO CONE ATTACHMENT 8378.90M manufactured by Richard Wolf Medical Instruments Corp..
| Report Number | 1418479-2019-00026 |
| MDR Report Key | 8741136 |
| Date Received | 2019-06-27 |
| Date of Report | 2019-06-04 |
| Date of Event | 2019-04-20 |
| Date Facility Aware | 2019-06-04 |
| Report Date | 2019-06-27 |
| Date Reported to FDA | 2019-06-27 |
| Date Reported to Mfgr | 2019-06-27 |
| Date Mfgr Received | 2019-07-16 |
| Device Manufacturer Date | 2015-06-23 |
| Date Added to Maude | 2019-06-27 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DAISY RAMOS |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal | 600613110 |
| Manufacturer Phone | 8479131113 |
| Manufacturer G1 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600613110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PORTIO CONE ATTACHMENT |
| Generic Name | PORTIO CONE ATTACHMENT |
| Product Code | HHI |
| Date Received | 2019-06-27 |
| Model Number | 8378.90M |
| Catalog Number | 8378.90M |
| Lot Number | 51004313 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Address | 353 CORPORATE WOODS PARKWAY VERNON HILLS IL 600613110 US 600613110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-27 |