MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-04-14 for METRX SYSTEM 9560802 manufactured by Warsaw Orthopedics.
[72783474]
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Patient Sequence No: 1, Text Type: N, H10
[72783595]
It was reported that patient underwent minimally invasive spine decompression surgery. Intra-op, light burned the patient's back. While in use, light was laying on patients back with rubber safety piece over where it attaches to light source. After case 'pa' stated that the light burned the patients back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2017-00813 |
| MDR Report Key | 6492549 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-04-14 |
| Date of Report | 2017-03-21 |
| Date of Event | 2017-03-21 |
| Date Mfgr Received | 2017-03-21 |
| Date Added to Maude | 2017-04-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GREG ANGLIN |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | WARSAW ORTHOPEDICS |
| Manufacturer Street | 2500 SILVEUS CROSSING |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| 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 | 2017-04-14 |
| Model Number | NA |
| Catalog Number | 9560802 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDICS |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-14 |