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 |