MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-11 for TI-CRON 88863186-41 manufactured by Covidien.
[40131438]
Patient Sequence No: 1, Text Type: N, H10
[40131439]
During radical resection of chondrosarcoma the needle bent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5494458 |
| MDR Report Key | 5494458 |
| Date Received | 2016-03-11 |
| Date of Report | 2016-03-07 |
| Date of Event | 2016-02-23 |
| Report Date | 2016-03-07 |
| Date Reported to FDA | 2016-03-07 |
| Date Reported to Mfgr | 2016-03-07 |
| Date Added to Maude | 2016-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI-CRON |
| Generic Name | NEEDLE |
| Product Code | GAO |
| Date Received | 2016-03-11 |
| Model Number | 88863186-41 |
| Lot Number | D4L0439X |
| ID Number | 2 METRIC 30" 75CM |
| Device Expiration Date | 2019-11-01 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-11 |