MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for INTEGRA LUXTEC MLX LIGHT SOURCE BOX 00MLX NA manufactured by Integra.
[177996142]
Pt sustained burn to left thigh after ureteral lighted stents were taped to left thigh. The portable light box was used to connect the ureteral lighted stents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092762 |
| MDR Report Key | 9671523 |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-29 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRA LUXTEC MLX LIGHT SOURCE BOX |
| Generic Name | LIGHT SOURCE, FIBEROPTIC, ROUTINE |
| Product Code | FCW |
| Date Received | 2020-02-04 |
| Model Number | 00MLX |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA |
| Brand Name | KARL STORZ LIGHTED URETERAL STENT |
| Generic Name | LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2020-02-04 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | PQ01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY - AMERICA |
| Brand Name | KARL STORZ LIGHT CORD |
| Generic Name | LIGHT, CATHETER, FIBEROPTIC, GLASS URETERAL |
| Product Code | FCS |
| Date Received | 2020-02-04 |
| Lot Number | ZT25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY - AMERICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |