MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-09-10 for MAST QUADRANT RETRACTOR SYSTEM 9560658 manufactured by Medtronic Sofamor Danek.
[1262356]
It was reported that the light source cord burned the pt at lower back during use and caused a two inches diameter second degree burn to the pt. No other pt complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[8315952]
Device was not returned to the manufacturer for evaluation. We are unable to determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2009-00833 |
| MDR Report Key | 1469154 |
| Report Source | 05,07 |
| Date Received | 2009-09-10 |
| Date of Report | 2009-07-20 |
| Date of Event | 2009-07-17 |
| Date Mfgr Received | 2009-07-20 |
| Date Added to Maude | 2009-09-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHAD ASHTON |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 7375 ADRIANNE PLACE |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAST QUADRANT RETRACTOR SYSTEM |
| Generic Name | ILLUMINATION |
| Product Code | FSZ |
| Date Received | 2009-09-10 |
| Model Number | NA |
| Catalog Number | 9560658 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Address | 7375 ADRIANNE PLACE BARTLETT TN 38133 US 38133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-09-10 |