MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-03-26 for BIVONA? ADULT TTS? TRACHEOSTOMY TUBE CUSTOM 4.0 FLEXTEND TTS NS +1/EA 60PFP60 manufactured by Smiths Medical Asd,inc..
[185197409]
Information was received that smiths bivona? Adult tts? Tracheostomy tracheostomy
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02277 |
| MDR Report Key | 9887052 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-26 |
| 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 NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. |
| Manufacturer Street | AVE CALIDAD NO. 4, PARQUE INDUSTRIAL INTERNACIONA |
| Manufacturer City | TIJUANA, B.C. 22425 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIVONA? ADULT TTS? TRACHEOSTOMY TUBE |
| Generic Name | TUBE TRACHEOSTOMY AND TUBE CUFF |
| Product Code | JOH |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-25 |
| Model Number | CUSTOM 4.0 FLEXTEND TTS NS +1/EA |
| Catalog Number | 60PFP60 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD,INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |