MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-01-07 for METRX SYSTEM 9560702 manufactured by Medtronic Sofamor Danek Usa, Inc.
[19754495]
(b)(4). Device was not returned to the manufacturer for evaluation. We are unable to determine the cause of the event. A review of device history records is not possible at this time without additional device information.
Patient Sequence No: 1, Text Type: N, H10
[19841319]
It was reported that the patient received mini-invasive discectomy procedure at l5-s1 two years ago and a illuminate system was used at the surgery. During the surgery, the light source where it plugs in was draped across the patient. After the surgery, it was noticed that the patient's back burned by the connector between light source and the cable. The burn area was treated in the or before the patient left the room. There was a circle mark left where the plug was draped over the patient. The patient reportedly received the post-op treatment for the burn. Reportedly, the patient had the dermatology issues after the treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2011-00021 |
| MDR Report Key | 1952966 |
| Report Source | 05,07 |
| Date Received | 2011-01-07 |
| Date of Report | 2010-12-16 |
| Date of Event | 2008-05-22 |
| Date Mfgr Received | 2010-12-16 |
| Date Added to Maude | 2011-02-01 |
| 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 | 3 |
| 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 | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | METRX SYSTEM |
| Generic Name | LIGHT, SURGICAL, CARRIER |
| Product Code | FSZ |
| Date Received | 2011-01-07 |
| Model Number | NA |
| Catalog Number | 9560702 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-01-07 |