MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-09-06 for GEMINI UNIVERSAL 5 MM FIBER OPTIC LIGHT CABLE 5.0 MM X 10 FT 7205178 manufactured by Smith & Nephew Plc.
| Report Number | 9610773-2017-00104 |
| MDR Report Key | 6844206 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-09-06 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-05-22 |
| Date Mfgr Received | 2017-10-23 |
| Date Added to Maude | 2017-09-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL WLADOW |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG |
| Manufacturer Country | US |
| Manufacturer Phone | 4940669662 |
| Manufacturer G1 | SCHOTT AG |
| Manufacturer Street | HATTENBERGSTRASSE 10 |
| Manufacturer City | MAINZ |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEMINI UNIVERSAL 5 MM FIBER OPTIC LIGHT CABLE 5.0 MM X 10 FT |
| Generic Name | FIBER OPTIC LIGHT CABLES AND ADAPTORS |
| Product Code | HBI |
| Date Received | 2017-09-06 |
| Model Number | 7205178 |
| Catalog Number | 7205178 |
| ID Number | 04042761082297 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW PLC |
| Manufacturer Address | 15 ADAM STREET LONDON WC2N6LA UK WC2N 6LA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Required No Informationntervention | 2017-09-06 |
| 1 | 0 | 1. Required No Informationntervention | 2017-09-06 |