MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-13 for LUMITEX LIGHT FIBER CABLE 683683 manufactured by Lumitex.
[3506597]
During a scheduled bilateral nipple sparing prophylactic mastectomy and immediate bilateral breast reconstruction, the surgeon who had a light mat on the sterile field, noted the pt had a burn to the midline of her chest. The device was removed from the sterile field and bactroban and xeroform was applied to the burn. Product investigation revealed the light fiber cable no longer fit tightly into the retractor, which inadvertently caused the end of the cable to fall out of the retractor and land on the pt's skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030199 |
| MDR Report Key | 3118409 |
| Date Received | 2013-05-13 |
| Date of Report | 2013-05-13 |
| Date of Event | 2012-12-14 |
| Date Added to Maude | 2013-05-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMITEX LIGHT FIBER CABLE |
| Generic Name | LIGHT FIBER CABLE |
| Product Code | FDG |
| Date Received | 2013-05-13 |
| Model Number | 683683 |
| Lot Number | CE30023 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMITEX |
| Manufacturer Address | 8443 DOW CIRCLE STRONGSVILLE OH 44136 US 44136 |
| Brand Name | LUMITEX DISPOSABLE LIGHT |
| Generic Name | LIGHT MAT |
| Product Code | FDG |
| Date Received | 2013-05-13 |
| Model Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | LUMITEX |
| Manufacturer Address | 8443 DOW CIRCLE STRONGSVILLE OH 44136 US 44136 |
| Generic Name | LIGHT SOURCE |
| Product Code | FDG |
| Date Received | 2013-05-13 |
| Model Number | S300T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | LUMITEX |
| Manufacturer Address | 8443 DOW CIRCLE STRONGSVILLE OH 44136 US 44136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-13 |