MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-11-10 for CV EVOLUTIONS SAPHLITE 89-2719 manufactured by Teleflex Medical.
[968873]
The complaint description was reported as: light got hot during a saphenous vein harvest. No pt injury or intervention reported.
Patient Sequence No: 1, Text Type: D, B5
[8139283]
No additional info available. Device returned for eval. Report of eval and investigation not available at time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2008-00038 |
| MDR Report Key | 1237518 |
| Report Source | 05,06 |
| Date Received | 2008-11-10 |
| Date of Report | 2008-10-16 |
| Date Mfgr Received | 2008-10-15 |
| Date Added to Maude | 2009-11-02 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA BROWN, MGR |
| Manufacturer Street | 4024 STIRRUP CREEK DR. |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CV EVOLUTIONS SAPHLITE |
| Generic Name | SAPHLITE |
| Product Code | FSW |
| Date Received | 2008-11-10 |
| Returned To Mfg | 2008-10-31 |
| Model Number | NA |
| Catalog Number | 89-2719 |
| Lot Number | 541205 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-10 |