MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2013-01-08 for COMBITUBE 37 FR ROLLUP 5-18437 manufactured by Covidien/ Formerly Tyco.
[3124492]
A report from (b)(6) advised that they had rec'd a report from a coroner's office wherein 3 cases of significant esophageal injuries were found at autopsy in pts intubated with the combitube by paramedics. The esophageal injuries were reported to have documented and photographed. This was reported to have occurred sometime in (b)(6) 2009, exact incident dates are unk.
Patient Sequence No: 1, Text Type: D, B5
[10425903]
Covidien made attempts to petition the coroner's release of further info regarding the pts and the reported injuries. No consent to release pt info was given. There was no allegation of a malfunction of the combitube and as noted, no info provided regarding the usage of the combitube.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317749-2013-00022 |
| MDR Report Key | 2912798 |
| Report Source | 00,01 |
| Date Received | 2013-01-08 |
| Date of Report | 2010-07-05 |
| Date of Event | 2009-06-01 |
| Date Mfgr Received | 2010-07-05 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2013-01-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HOLLY GOMES, QA SUPERVISOR |
| Manufacturer Street | 5870 STONERIDGE DR. SUITE 6 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9254634612 |
| Manufacturer G1 | COVIDIEN/ FORMERLY TYCO HEALTHCARE |
| Manufacturer Street | 5439 STATE ROUTE 40 |
| Manufacturer City | ARGYLE NY 12809 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12809 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMBITUBE 37 FR ROLLUP |
| Generic Name | ESOPHAGEAL AIRWAY TUBE |
| Product Code | CAO |
| Date Received | 2013-01-08 |
| Catalog Number | 5-18437 |
| Lot Number | 716602 |
| ID Number | RX201007-0231 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN/ FORMERLY TYCO |
| Manufacturer Address | 5439 STATE ROUTE 40 ARGYLE NY 12809 US 12809 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-08 |