MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-04-01 for UNKNOWN TICRON UNKNOWN-TICRON manufactured by Covidien.
[5611048]
Procedure: sternotomy. According to the reporter: thymus tumor on a (b)(6) female patient, (b)(6). The surgeon performed a sternotomy on 2/3 length of the sternum. For the closure the surgeon used ticron, size 5. The dehiscence was after some weeks of the procedure.
Patient Sequence No: 1, Text Type: D, B5
[13034059]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2015-00194 |
| MDR Report Key | 4650111 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-03-04 |
| Date Mfgr Received | 2015-03-04 |
| Date Added to Maude | 2015-04-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 |
| Manufacturer City | SANTO DOMINGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN TICRON |
| Generic Name | TICRON SUTURE |
| Product Code | GAO |
| Date Received | 2015-04-01 |
| Model Number | UNKNOWN-TICRON |
| Catalog Number | UNKNOWN-TICRON |
| Lot Number | NOT AVAILABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 SANTO DOMINGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-01 |