MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-07 for METRX SYSTEM 9560702 manufactured by Warsaw Orthopedics.
[138068346]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. Although it is unknown if the device caused or contributed to the reported event or not, we are filing this report for notification purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[138068347]
It was reported that intra-op, heat burn to patient's back where connection of light source to light cord attaches. Radiance light source used with size 20 tubes. The protective covering was not slid over the light source to light cord connection. After first tlif was complete, burns were noticed on the patients back and identified to be caused by the light source/light cord connection. A vaseline gauze was immediately placed on the burn, and the covering slid over the light source to light cable connection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-00238 |
| MDR Report Key | 8398212 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-02-08 |
| Date Mfgr Received | 2019-02-08 |
| Device Manufacturer Date | 2017-11-14 |
| Date Added to Maude | 2019-03-07 |
| 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 | STACIE ZIEMBA |
| 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 | 2019-03-07 |
| Model Number | NA |
| Catalog Number | 9560702 |
| Lot Number | 0601680W |
| 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 | 2019-03-07 |