MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-11-18 for SMITHS MEDICAL UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY 100/897/070 manufactured by Smiths Medical Asd, Inc..
| Report Number | 3012307300-2019-06246 |
| MDR Report Key | 9336970 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-11-18 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-07-11 |
| Date Mfgr Received | 2019-11-11 |
| Date Added to Maude | 2019-11-18 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDARY ROAD, |
| Manufacturer City | HYTHE, KENT CT216JL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CT216JL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITHS MEDICAL UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY |
| Generic Name | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) |
| Product Code | BTO |
| Date Received | 2019-11-18 |
| Catalog Number | 100/897/070 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-18 |