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 2019-08-14 for PORTEX? UNIPERC? ADJUSTABLE FLANGE TRACHEOSTOMY TUBES 100/897/090 manufactured by Smiths Medical Asd; Inc..
| Report Number | 3012307300-2019-04191 |
| MDR Report Key | 8895414 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-08-14 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-07-19 |
| Date Mfgr Received | 2019-11-08 |
| Date Added to Maude | 2019-08-14 |
| 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 Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | HYTHE, CT216JL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CT21 6JL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX? UNIPERC? ADJUSTABLE FLANGE TRACHEOSTOMY TUBES |
| Generic Name | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) |
| Product Code | BTO |
| Date Received | 2019-08-14 |
| Returned To Mfg | 2019-10-08 |
| Catalog Number | 100/897/090 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Life Threatening; 2. Required No Informationntervention | 2019-08-14 |