MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for SNOWDEN-PENCER DIAMOND VIEW RETRACTOR SYSTEM 88-1001 manufactured by Carefusion 2200, Inc.
[178335558]
Patient was undergoing a breast implant expander surgery/breast reconstruction, left and right with revision of axillary scar-1 1/2 hr procedure, with lighted retractors. Fiber optic retractors used with a fiber optic light system. The fiber optic cable connector (which attaches the retractor to the power source))heated up and transmitted heat to the patient resulting in a burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9686477 |
| MDR Report Key | 9686477 |
| Date Received | 2020-02-10 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-11-13 |
| Report Date | 2020-01-03 |
| Date Reported to FDA | 2020-01-03 |
| Date Reported to Mfgr | 2020-02-10 |
| Date Added to Maude | 2020-02-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SNOWDEN-PENCER DIAMOND VIEW RETRACTOR SYSTEM |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | GAD |
| Date Received | 2020-02-10 |
| Model Number | 88-1001 |
| Catalog Number | 88-1001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC |
| Manufacturer Address | 5 SUNNEN DR SAINT LOUIS MO 63143 US 63143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-10 |