MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-08 for F/O CABLE ACMI/ACMI 7.5' 88-9727 * manufactured by Cardinal Health (snowden Pencer).
[356533]
During a breast aug. Patient was burned by light cord connector-also cord itself was much hotter than ever before. At the end of case a raised fluid blister was noted. Tegaderm placed by doctor. 8/2004 antibiotic applied by doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038548-2004-00023 |
| MDR Report Key | 542563 |
| Date Received | 2004-09-08 |
| Date of Report | 2004-09-08 |
| Date of Event | 2004-08-06 |
| Date Facility Aware | 2004-08-06 |
| Report Date | 2004-09-08 |
| Date Mfgr Received | 2004-08-06 |
| Date Added to Maude | 2004-09-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8477853309 |
| Manufacturer G1 | CARDINAL HEALTH (SNOWDEN PENCER) |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F/O CABLE ACMI/ACMI 7.5' |
| Generic Name | * |
| Product Code | FSX |
| Date Received | 2004-09-08 |
| Returned To Mfg | 2004-08-18 |
| Model Number | 88-9727 |
| Catalog Number | * |
| Lot Number | 779401 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 531931 |
| Manufacturer | CARDINAL HEALTH (SNOWDEN PENCER) |
| Manufacturer Address | * MCGAW PARK IL * US |
| Baseline Brand Name | F/O CABLE ACMI.ACMI 7.5 |
| Baseline Generic Name | * |
| Baseline Model No | 88-9727 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-08 |