MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-02-13 for 930 * manufactured by Coherent Medical Laser Group.
[18439814]
Device delivered 2 watts of energy while treating a pt. The incident occurred while treating the far periphery, so the dr does not feel the pt's vision was compromised. However, in another situation, this could be serious.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2914019-1997-00003 |
| MDR Report Key | 70349 |
| Report Source | 07 |
| Date Received | 1997-02-13 |
| Date of Report | 1997-02-13 |
| Date of Event | 1997-01-13 |
| Date Mfgr Received | 1997-01-14 |
| Date Added to Maude | 1997-02-24 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 930 |
| Generic Name | OPHTHALMIC ARGON PHOTOCOAGULATOR |
| Product Code | HQB |
| Date Received | 1997-02-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | K844356 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 70265 |
| Manufacturer | COHERENT MEDICAL LASER GROUP |
| Manufacturer Address | 3270 W. BAYSHORE RD. PALO ALTO CA 943030810 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-02-13 |