MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-12-20 for DORNIER HOLMIUM LASER FIBER DUR400D manufactured by Dornier Medtech America, Inc..
[773415]
No light is coming out of the end of the fiber, tested with no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037955-2007-00065 |
| MDR Report Key | 972372 |
| Report Source | 08 |
| Date Received | 2007-12-20 |
| Date of Report | 2007-12-20 |
| Date of Event | 2007-05-25 |
| Date Mfgr Received | 2007-11-20 |
| Device Manufacturer Date | 2007-03-31 |
| Date Added to Maude | 2008-04-14 |
| 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 | THERON GOBER |
| Manufacturer Street | 1155 ROBERTS BLVD. |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7705146204 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNIER HOLMIUM LASER FIBER |
| Generic Name | LASER FIBER |
| Product Code | LNK |
| Date Received | 2007-12-20 |
| Returned To Mfg | 2007-11-20 |
| Model Number | DUR400D |
| Catalog Number | DUR400D |
| Lot Number | B1207S |
| Device Expiration Date | 2010-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 977758 |
| Manufacturer | DORNIER MEDTECH AMERICA, INC. |
| Manufacturer Address | KENNESAW GA 30144 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-20 |