MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-01-28 for CABLE HEADLIGHT STANDARD 7.5FT 001445 manufactured by Integra Luxtec, Inc..
[1442222]
Operating room materials manager and risk manager reported that a pt was burned (3rd degree blistering, later needing d? Bridement) on the anterior chest wall during a mastectomy on (b) (6) 2010. They are not sure which instruments/cables were in use during the surgery. Possible items used include the: luxtec (b) (4) head light cable (this is not an instrument cable) is used with the snowden pencer retractor. Snowden pencer fiber optic cable (part# unk). Snowden pencer retractor part #88-1087. Pilling-xenalight-300 (light source-part# unk). Snowden pencer connectors (part# unk). On (b) (6) 2010, conversation with risk mgr - she states, they think, the burn was caused by the snowden pencer cable, not the luxtec cable. Degree of injury was also reported at this time.
Patient Sequence No: 1, Text Type: D, B5
[8348323]
To date the device involved in the reported incident has not been rec'd for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221336-2010-00001 |
| MDR Report Key | 1592698 |
| Report Source | 06 |
| Date Received | 2010-01-28 |
| Date of Report | 2010-01-28 |
| Date of Event | 2009-10-21 |
| Date Mfgr Received | 2010-01-04 |
| Date Added to Maude | 2010-03-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 DR |
| 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 | CABLE HEADLIGHT STANDARD 7.5FT |
| Generic Name | NA |
| Product Code | EQH |
| Date Received | 2010-01-28 |
| Catalog Number | 001445 |
| 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 | 2010-01-28 |