MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2012-09-20 for COMBITUBE 5-18537 manufactured by Covidien/formerly Tyco Healthcare.
[16045582]
Customer states: prior to use on a patient, the balloon broke while checking the balloon. Customer confirmed no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[16242499]
The sample associated to this report is expected to be returned for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2012-00485 |
| MDR Report Key | 2756100 |
| Report Source | 00,01 |
| Date Received | 2012-09-20 |
| Date of Report | 2012-08-23 |
| Date of Event | 2012-08-22 |
| Date Mfgr Received | 2012-08-23 |
| Date Added to Maude | 2013-01-09 |
| 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, 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 | 1181 PARQUE INDUSTRIAL SALVARCAR AVENIDA HENEQUEN |
| Manufacturer City | CD. JUAREZ, CHIHUAHUA CO |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMBITUBE |
| Generic Name | ESOPHAGEAL TRACHEAL TUBE |
| Product Code | CAO |
| Date Received | 2012-09-20 |
| Catalog Number | 5-18537 |
| ID Number | RX201209-0247 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN/FORMERLY TYCO HEALTHCARE |
| Manufacturer Address | AVENIDA HENEQUEN CD. JUAREZ, CHIHUAHUA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-20 |