MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-29 for MAVIG - PORTEGRA 2 OT60U01 * manufactured by Mavig Gmbh.
[578285]
Upon moving the lead shield during a patient procedure, one of the covers fell off of one of the joints and hit the patient in the face, resulting in a scratch to the left eye. (mavig arm-portegra 2)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 814545 |
| MDR Report Key | 814545 |
| Date Received | 2007-01-29 |
| Date of Report | 2007-01-25 |
| Report Date | 2007-01-25 |
| Date Reported to FDA | 2007-01-29 |
| Date Added to Maude | 2007-02-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAVIG - PORTEGRA 2 |
| Generic Name | X-RAY, SHIELD |
| Product Code | KPY |
| Date Received | 2007-01-29 |
| Model Number | OT60U01 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 802029 |
| Manufacturer | MAVIG GMBH |
| Manufacturer Address | 25 HYTEC CIRCLE ROCHESTER NY 146064255 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-29 |