MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-02-28 for MAVIG - PORTEGRA 2 OT60U01 * manufactured by Ti-ba Enterprises, Inc..
[15039068]
Upon moving the lead shield during a pt procedure, one of the covers fell off of one of the joints and hit the pt in the face, resulting in a scratch to the left eye. (mavig arm-portegra 2). Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
[15134347]
We have tried on several occasions to reach director of radiology to learn more about this incident. Leaving messages on 2/19, 2/22, 2/28, but to this point we have not gotten a response or had the opportunity to complete an investigation. Due to the time sensitivity, we are submitting our report without their input. It was a device abuse situation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2438931-2007-00001 |
| MDR Report Key | 847120 |
| Report Source | 06 |
| Date Received | 2007-02-28 |
| Date of Report | 2007-01-25 |
| Date Facility Aware | 2007-02-19 |
| Report Date | 2007-02-28 |
| Date Reported to Mfgr | 2007-02-19 |
| Date Mfgr Received | 2007-02-19 |
| Date Added to Maude | 2007-05-15 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRAIN MCKEON |
| Manufacturer Street | 25 HYTEC CIRCLE |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal | 14606 |
| Manufacturer Phone | 5852471212 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAVIG - PORTEGRA 2 |
| Generic Name | LEAD |
| Product Code | KPY |
| Date Received | 2007-02-28 |
| Model Number | OT60U01 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | * |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 802029 |
| Manufacturer | TI-BA ENTERPRISES, INC. |
| Manufacturer Address | 25 HYTEC CIRCLE ROCHESTER NY 14606 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-02-28 |