MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-12-11 for CABLES, GAL300F6.0-NA-G 2B300F60A0 manufactured by Integra Luxtec, Inc..
[1451799]
The customer reports that upon first use of the cable the patient was burned. The customer reports that the specific devices used with the cable are retractors that were manufactured by assi and snowden-pencer, and the light source by dyonics (xenon xl - (b)(4)). Seeking additional information from the physician re: extent of burn and treatment. Physician reports via telephone 12/10/2009 that a breast implant exchange was being performed using a lighted reactor. The patient sustained a cutaneous burn from the end of the cable that connects to the retractor. Physician reports indeterminate degree of burn. The burn was treated with ointment and a dressing.
Patient Sequence No: 1, Text Type: D, B5
[8347945]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221336-2009-00006 |
| MDR Report Key | 1559661 |
| Report Source | 06 |
| Date Received | 2009-12-11 |
| Date of Report | 2009-12-10 |
| Date Mfgr Received | 2009-12-03 |
| Date Added to Maude | 2010-09-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE, RN, BSM |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CABLES, GAL300F6.0-NA-G |
| Generic Name | CABLES |
| Product Code | EQH |
| Date Received | 2009-12-11 |
| Catalog Number | 2B300F60A0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LUXTEC, INC. |
| Manufacturer Address | WEST BOYLSTON MA 01583 US 01583 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-11 |